Information and misinformation on assisted human reproduction techniques in Europe: a normative analysis of the information provided on the websites of medically assisted reproduction clinics

Abstract

Background

As part of the European Be better informed about Fertility project (B2-InF), we carried out a normative analysis of the information provided online by assisted reproduction clinics to the European public. This analysis aimed to determine the degree to which this information complies with regulations of medically assisted reproduction (MAR) and commercial information, and the main ethical implications related to the duty of information.

Methods

Information was gathered from the websites of 33 clinics across 8 European countries (Albania, Belgium, Spain, Italy, Kosovo, Northern Macedonia, Slovenia, Switzerland). Nearly 2000 pages of information were reviewed and checked for compliance with relevant frameworks of national and international law.

Results

The assessment revealed significant inconsistencies in how clinics present information online, with particular concerns regarding transparency about success rates, associated risks, add-on techniques and the legal and ethical issues that may arise during the use of these techniques.

Conclusions

The results of our analysis indicate an urgent need for enhanced regulatory oversight and standardized information requirements for assisted reproduction clinics across Europe. These findings suggest the necessity for harmonized legal frameworks that mandate comprehensive disclosure standards and establish effective enforcement mechanisms to ensure transparent and accurate information provision to potential patients.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12910-026-01388-5.

Background

According to the last ESHRE report on Medical Assisted Reproduction (MAR) and Intrauterine insemination (IUI), a progressive increase in reported treatment cycle numbers in Europe was detected in 2020. A total of 1157 clinics offering MAR services in 35 countries reported a total of 713,708 treatment cycles [1]. This substantial and growing number of treatment cycles reflects the increasing reliance on assisted reproduction technologies across Europe, where MAR has become an important healthcare service for individuals and couples facing fertility challenges.

However, this expanding demand is met through a highly fragmented system. The European ART landscape is highly fragmented and structurally dependent on national funding policies. Only countries providing near-total or very high state reimbursement—such as Belgium, Denmark, and Slovenia—achieve the ESHRE-recommended benchmark of at least 1,500 cycles per million inhabitants necessary to meet infertility treatment demand [2].

Most European nations operate mixed models with limited public funding, making the system heavily reliant on private resources. Countries like Bulgaria, Romania, and Spain reimburse only 20–30% of treatment costs, transferring the substantial financial burden directly to patients through significant out-of-pocket expenditure. Consequently, the majority of ART treatments across Europe are conducted within a flourishing private sector. Private clinics operate as competitive enterprises, absorbing demand unmet by public systems.

Given this predominantly private healthcare context, where patients must navigate treatment options largely independently and often make initial decisions based on information found online, the question arises: are assisted reproduction clinics providing European citizens with accurate, complete, and legally compliant information about these techniques through their websites?

As part of the B2-InF project,1 we attempted to answer this question, albeit partially, from a legal perspective, by analyzing whether the commercial information that clinics make available to potential users and the general public through their websites complies with existing legal standards and consumer protection requirements.

In vitro fertilization (IVF) websites are among the primary means by which the European public is informed about IVF practices. Moreover, this information is one of the main bases for making a decision about whether to undergo fertility treatment, which clinic to choose, and which services to use [3, 4]. However, in a competitive environment where most clinics operate as private enterprises vying for clients in a healthcare marketplace, without specific sectoral regulation, the information displayed by clinic websites may be misleading [5, 6].

Some preliminary remarks on the type of information analyzed will help to understand why clinics have legal obligations not only toward their patients but also toward the recipients of the information they provide on their websites.

From a normative perspective, users of MAR are "consumers" whenever this service is offered by a private clinic with whom the user enters a commercial contract. This condition applies to all of the cases analyzed here, which means that laws of consumer protection apply to the information provided by clinics through their websites. Within the scope of the European Union, the main objective of the Consumer Protection Directive (D2011/83/EU, on consumer rights) is to guarantee the consumer's right to information, together with other rights such as the protection of health, safety, and economic and legal interests of European consumers, regardless of where they live—that is, including consumers who travel to or from, make purchases or use services within the EU. As explained later, non-EU countries analyzed have incorporated the content of the EU regulations on advertising and consumer protection into their domestic law.

It could be argued that the philosophy of the current regulation of commercial information can be condensed into the statement that an informed consumer is an empowered consumer [7]. This principle aligns closely with the ethical imperative of respecting patient autonomy in assisted reproduction, which requires that individuals have access to adequate, accurate, and comprehensible information to make voluntary and autonomous decisions about their reproductive healthcare [8].

In this sense, whenever someone engages in a commercial act of consumption, whether buying a product or contracting a service, that person must have all the information required to make an informed decision (D2011/83/EU, art. 5). Accordingly, someone who is considering whether to hire the services of a clinic has the right to receive all the necessary information for making a well-founded judgment about the services or treatments offered by that clinic. Without complete and truthful information, the foundational conditions for autonomous decision-making are fundamentally compromised.

If a service is contracted on the basis of this incorrect information, or without having received all the essential information, the client can claim that the contract is void on the grounds that his or her consent was invalid. In other words, there would be a “vice of consent” caused by errors or other inadequacies of the information provided [9].

In areas where there is specific regulation of commercial information (e.g., in the case of advertising for financial services, tourist contracts, tobacco, alcohol, medicines, games), the required essential information is clearly defined, as it is included in the sectoral regulation. In areas where there is no sectoral regulation, as is the case with MAR in Europe, information must comply with the general rules for consumer protection and with the advertising and contract laws of each country. In general, the client must be given objective information about all essential elements of the product or service so that he or she can decide whether to enter into a commercial contract with full knowledge of the facts.

It is not always mandatory that all the essential content related to the product or service appears in the advertising carried out by the company. This depends on the type of advertising used by the advertiser. From a normative perspective, two kinds of advertising can be distinguished [10]:

• a) Advertising as a mere publicity claim, where the advertiser has no legal liability or responsibility for the content.

• b) Informative advertising containing the essential elements of the contract (price and essential characteristics of the product or service offered). In this case, the information contained in advertising constitutes a "contract offer" with a binding value for the company.

MAR clinic websites seem to be engaging in informative advertising, as all of them provide detailed information about the treatments offered to patients. However, some essential kinds of information, such as data about risks and success rates, may be hidden or only partially disclosed. If a company adopts the form of "informative advertising," it must be consistent and provide all the information necessary for the potential customer to make an informed judgment. If this is not the case, this constitutes a case of misleading advertising: a distorted reality is presented to the client owing to the partial absence or misrepresentation of essential information (D2006/114/EC concerning misleading and comparative advertising2).

According to normative regulations for advertising, then, the clinic is liable for misleading advertising not only if the information provided is false but also if essential information is omitted or if information is provided inappropriately.

Given this regulatory framework and the critical role that website information plays in patient decision-making, this study examines the extent to which fertility clinic websites in the countries analyzed provide complete and balanced information to potential patients. Specifically, we investigate whether the information currently offered by clinics meets the standards required for informed decision-making, and identify areas where improvements could enhance compliance with consumer protection principles and support patient autonomy. Rather than focusing solely on detecting misleading practices, our aim is to assess the current state of information provision and suggest pathways for clinics to optimize their communication strategies in alignment with legal requirements and patients' informational needs.

Methods

In the framework of the B2-InF Project, the information provided by the websites of 34 medical centers in 8 countries (Albania, Belgium, Spain, Italy, Kosovo, Northern Macedonia, Slovenia, Switzerland) was analyzed from a normative standpoint. This analysis involved comparing this information with the relevant national and international normative frameworks of (i) MAR and (ii) commercial information.

Selection of the countries under analysis

The study covered eight European countries (Belgium, Switzerland, Spain, Italy, North Macedonia, Albania, Slovenia, and Kosovo) selected to ensure maximum diversity in socio-cultural, regulatory, and institutional contexts related to assisted human reproduction. This selection also corresponded to the countries where members of the Be Better Informed about Fertility (B2-InF) consortium were based, allowing direct access to linguistic, legal, and contextual expertise, as well as to reliable local data sources. The presence of consortium partners in these countries made it feasible to carry out a cross-national comparison while maintaining methodological coherence and contextual accuracy.

The inclusion of both EU member states (Belgium, Spain, Italy, Slovenia) and non-EU or transitional countries (Switzerland, North Macedonia, Albania, Kosovo) provided an opportunity to capture contrasting regulatory frameworks and sociocultural norms. Previous B2-InF work has shown that perceptions of fertility and reproductive technologies vary substantially across Europe [11]. Building on that evidence, the selection of countries aimed to reflect this heterogeneity while remaining consistent with the project’s comparative and normative design.

A total of 34 websites belonging to medically assisted reproduction (MAR) clinics were included in the analysis. The number of websites per country varied according to the size of the national market, the online visibility of clinics, and the information available in local languages. This sample reflects the uneven distribution of ART services across Europe, ranging from highly developed and regulated sectors (Belgium, Spain) to smaller or emerging ones (Albania, Kosovo). Although limited in number, the sample was sufficiently diverse to capture the main patterns and inconsistencies in how clinics present legal, ethical, and medical information to prospective patients. Our analysis focuses specifically on publicly accessible website information, which represents the primary source for the general public—particularly young people—before clinical engagement. We attempted to obtain additional patient materials such as information sheets and informed consent forms directly from the clinics; however, none provided these documents.

Clinic websites were identified through a systematic and replicable search strategy combining online and institutional sources. Searches were conducted primarily on Google, using combinations of country names and relevant keywords in both English and the respective national languages (e.g., “IVF clinic,” “assisted reproduction,” “fertility treatment,” “insemination,” “infertility,” and “ICSI”). These terms correspond to the most common search words used by patients seeking fertility treatments online, ensuring that the selected websites were those most likely to be encountered by potential users [11]. Search results were screened in order of appearance, excluding magazines, blogs, and clinics without their own laboratory or without an active website. When available, official registries of fertility clinics, directories provided by national health authorities, and professional association lists were also consulted to validate and complement the search results. Each list was reviewed by native researchers within the B2-InF consortium to ensure accuracy and completeness.

Clear inclusion and exclusion criteria were applied across all countries. Websites were included if they belonged to clinics offering at least one medically assisted reproduction procedure (IVF, ICSI, IUI, gamete donation) and contained publicly available information directed at patients or prospective patients. Only websites that were active and accessible during the data collection period (from June to August 2023) and that provided information related to success rates, associated risks, or ethical and legal aspects of ART were included. Excluded websites comprised aggregator portals, directories, non-clinic pages, and purely promotional sites lacking substantive medical or ethical content. Duplicates (for example, multiple branches of the same clinic with identical content) were also excluded, as were websites unavailable for technical reasons during the entire collection period.

Once the websites were identified, the content was examined using a structured template designed within the B2-InF project. The sampling frame—comprising the clinic websites included in the study—is listed in Table 1. The template categorised the extracted information by theme, including legal and ethical disclosures, terminology used to report success rates (live birth, clinical pregnancy, biochemical pregnancy), differentiation of results by age and technique (e.g., artificial insemination, IVF/ICSI, with or without gamete donation), quantitative descriptions of treatment effectiveness, and references to certification or auditing by external bodies. Both textual and graphical materials were analyzed to assess the presence, absence, or ambiguity of relevant information. The checklist used for website assessment and the anonymised dataset are publicly available in the B2-InF project repository on Zenodo [11].

Table 1.

List of the medically assisted reproduction (MAR) clinics analyzed, by country

Country	Clinic name	Website
Spain	IVI	https://ivi.es
	Instituto Bernabeu	https://www.institutobernabeu.com institutobernabeu.com
	Institut Marquès	https://institutomarques.com/en/ Institut Marquès
	Ginefiv	https://www.ginefiv.com/en/ Ginefiv España
	FIV Valencia	https://www.fivvalencia.com/en/ fivvalencia.com
Belgium	Brussels IVF (UZ Brussel)	https://www.brusselsivf.be/en/ Brussels IVF
	CHIREC – Fertility Centre	https://chirec.be/en/fertility-centre-hbw chirec.be
	CPMA – Université de Liège	https://cpma-ulg.be/ CPMA
	GHdC – Grand Hôpital de Charleroi (Centre médical de la reproduction)	https://www.ghdc.be/services/centre-medical-de-la-reproduction-pma ghdc.be
	Hôpital Erasme – Clinique de la fertilité	https://www.erasme.be/fr/clinique-de-la-fertilite-pma Hôpital Erasme
Switzerland	360° Kinderwunschzentrum Zürich	https://www.360grad.ch/en/ 360grad.ch
	CPMA Lausanne (Clinique Cecil/Hirslanden)	https://www.cpma.ch/en-us/CPMA cpma.ch
	Kinderwunschzentrum Baden	https://kinderwunschbaden.ch
	OVA IVF Clinic Zurich	https://ova-ivf.ch/ ova-ivf.ch
Kosovo	American Clinic “Dr. Behar Kusari”	https://american-art.net/en/home/ Klinika Amerikane “Dr Behar Kusari”
	Spitali Special Bahçeci (Kosovo)	https://bahceci.com/en/our-centers/kosovo-women-speciality-hospital/ Bahçeci Sağlık Merkezi
	European Clinic Kosova	Ballina – English – European Clinic
	FATI IM Spitali	https://fatiim.com/ fatiim.com
Albania	Hygeia Hospital Tirana – IVF Fertility Clinic	https://hygeia.al/en/department/ivf-fertility-clinic/ Spitali Hygeia Tiranë
	IVF Center ADC (Ana Diagnostic Center)	https://anadc.com/index.php/ivf-center/
	Klinika Gliozheni	https://klinikagliozheni.com/en/ klinikagliozheni.com
	Spitali Americani (American Hospital Tirana) – IVF	https://al.spitaliamerikan.com/en/department/in-vitro-fertilisation-ivf/ al.spitaliamerikan.com
	Qendra e Fertilitetit “Ursula”	https://ursula-ivf.al
North Macedonia	PHI Ginekomedika	https://ginekomedika.com.mk
	New Born Clinic	https://www.newborn.mk/en/ newborn.mk
	PLODNOST Bitola	https://plodnost.com.mk/ Hospital Plodnost
	PHI Re-Medika	https://remedika.com.mk
Slovenia	Health Center Dravlje (ZCD) – Neplodnost	https://www.neplodnost.com/en/home/ neplodnost.com
	UKC Maribor – IVF	https://www.ukc-mb.si/ivf/ ukc-mb.si
Italy	G.EN.E.R.A. (Genera PMA)	https://www.generapma.it
	Humanitas Research Hospital – Fertility Center	https://www.humanitas.it
	IVI Italia	https://ivitalia.it
	R.A.P.R.U.I. s.r.l	https://raprui.com
	Biogenesi (Centro di Medicina della Riproduzione)	www.biogenesi.it

Determining the relevant law and soft law

As far as the analysis of the legal state of regulation is concerned, proceeded differently according to the criteria of the EU country/third country, using different databases for the EU countries, such as Eurlex (European Law) and IURE (European case law), and for national regulation: n-Lex; Iurifast and Dec Nat; Common Portal of Case Law. Moreover, for third countries involved in B2inf, information was obtained from official sources, especially from the websites of governments, parliaments, and relevant international organizations in Kosovo, Macedonia, Albania and Switzerland. A summary of the key legal and ethical frameworks governing ART in the analysed countries is provided in Table 2.3

Table 2.

Summary of key legal and ethical frameworks governing ART in the analysed countries

Country	Main legal framework	Permitted ART practices (key points)	Ethical/oversight mechanisms
Belgium	Law on Medically Assisted Reproduction and the Disposition of Supernumerary Embryos and Gametes (2007)	Wide access, including single women and same-sex couples; gamete and embryo donation allowed; embryo research permitted under conditions	Ethical committees in hospitals; federal bioethics oversight
Switzerland	Federal Law on Medically Assisted Reproduction (LPMA, 1998, revised 2017)	Access limited to heterosexual couples; gamete donation allowed; embryo research tightly restricted; surrogacy prohibited	Federal Office of Public Health (FOPH) supervision; cantonal ethics committees
Spain	Law 14/2006 on Assisted Human Reproduction Techniques	Broad access, including single women; gamete donation anonymous; preimplantation genetic testing regulated; surrogacy prohibited	National Commission on Assisted Human Reproduction (CNRHA) oversight
Italy	Law 40/2004 (and subsequent Constitutional Court rulings)	Initially restrictive; post-2014 rulings allow donor gametes and heterologous fertilisation; surrogacy prohibited; embryo research banned	Ministry of Health and National Bioethics Committee supervision
Slovenia	Infertility Treatment and Procedures of Biomedically Assisted Procreation Act (2000)	Access for married or cohabiting heterosexual couples; gamete donation permitted; embryo donation and surrogacy not allowed	National Ethics Commission oversight
North Macedonia	Law on Biomedically Assisted Fertilisation (2008, amended 2018)	Access mainly for married couples; gamete donation regulated; embryo donation permitted; surrogacy permitted under specific conditions	State Sanitary and Health Inspectorate supervision
Albania	Law on Reproductive Health (2002, amended 2011)	Permits IVF and gamete donation; access restricted to heterosexual couples; surrogacy not regulated	Ministry of Health oversight; limited ethical regulation
Kosovo	Law on Reproductive Health (2012)	Allows IVF and gamete donation; surrogacy prohibited; limited provisions on embryo research and genetic testing	Ministry of Health supervision; ethical oversight under development

Defining essential information: Selection of evaluation criteria

What is "essential information" for contracting the services of a fertility clinic? Since it is the quality of the information concerning essential elements of the contractual relationship that determines whether or not we are dealing with misleading advertising, it is crucial to identify the essential elements of information about MAR; that is, the normative analysis of web-based information provided by clinics requires prior determination of its essential elements. To identify these elements, we proceed according to interpretative rules commonly used in the legal world to specify the meaning of indeterminate key concepts such as “essential information.”

There are two types of standards used to impute liability (that is, to establish legal obligations), which are often intertwined: technical standards (e.g., lex artis) and general standards of care (the good parent, the average consumer), which ultimately refer to social standards of reasonableness [12].

If we adopt the latter standard, our question is reformulated as follows: what does the average consumer need to know about MAR to obtain an adequate idea of the services being offered and to provide informed consent? We suggest that the following four elements belong to “essential information” as defined by this standard.

Success rates are clearly an essential element, perhaps the most essential element of information provided by clinics. Their importance is reflected by the American Society for Assisted Reproductive Technology (SART) policy for advertising. The purpose of this policy is to provide precise guidelines for the reporting of success rates [13], as they are considered to be a decisive element in decision making about MAR [13, 14].

Information about MAR treatment risks—for both patient and embryo—is also essential for informed decisions. Data collected from studies of the risks associated with the use of MAR are gradually accumulating and becoming known to the wider public [15]. In general, information about risks on the basis of the best evidence available is considered essential for any health intervention. In the case of MAR, studies have shown that errors in information are among the main causes of claims against clinics for malpractice [16].

The scientific evidence base for proposed treatments constitutes a third essential information element. Treatment add-ons (optional interventions offered alongside proven fertility treatments at additional cost) deserve special scrutiny. These procedures are characterized by insufficient or absent evidence of their effectiveness in clinical settings, and in some cases may even reduce treatment success [17].

The legality of the service to be contracted and its ethical implications are other essential elements in shaping the consumer's will. According to the legal principle "in law, ignorantia juris non excusat", the user will have to face the consequences if the contract is made, and the circumstances of the baby’s arrival into the world do not produce (or not immediately) the legal effects sought by the contractor. When a person turns to the services of clinics to become a parent, they are not only seeking a pregnancy, but it is also essential to understand the conditions under which the child, resulting from the use of these techniques, can be their child in legal terms. That is, how filiation is established and to what extent the use of certain services can represent an obstacle for the legal recognition of the child as the contractor’s child according to his/her domestic law. This occurs, as we will see later, in the case of surrogacy, and it can occur in certain uses of gametes from an anonymous donor.

On the other hand, given the profound ethical implications of certain techniques, clinics should inform prospective patients about the existence of an ongoing public debate regarding certain services they offer—particularly those commonly identified as ethically contentious. Clinics should be sensitive to the possibility that specific treatment components may raise ethical dilemmas for individual patients.

Results

Normative framework of medically assisted reproduction techniques and commercial information: general overview and key findings

Next, a general description of the normative framework is provided, distinguishing the regulation of MAR from the regulation of the advertising related to it.

Two ways of understanding assisted human reproduction techniques

While a growing number of jurisdictions are becoming more homogeneous, Europe remains a patchwork of local legislation with respect to MAR [18], and in each country, the strengths and weaknesses of these regulations continue to be debated.

However, a minimum—albeit very minimal—common regulatory framework exists, primarily concerning access to techniques. This stems from the fact that all analyzed countries except Kosovo are members of the Council of Europe and therefore fall within the jurisdiction of the ECtHR (insofar as the protection of fundamental rights is concerned). The Court has issued several relevant rulings on matters related to assisted reproduction, such as Costa and Pavan v. Italy (See Table in Annex) which have established certain fundamental rights protections, including recognition that claims to become parents are grounded in the right to respect for private and family life (Article 8 ECHR).

With respect to the Oviedo Convention (Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with Respect to the Applications of Biology and Medicine), all analyzed states except Kosovo, Italy, and Belgium are party to it.

Shifting focus to the legislative structure itself, the regulations of MAR in most countries need review. In the case of Eastern countries, particularly Albania and Kosovo, the development of more comprehensive regulation is needed, since both countries currently rely on general reproductive health frameworks that provide only very limited guidance on the use of these techniques. In other countries such as Italy, where regulation is more extensive, our analysis reveals the existence of legislation fragmented across multiple texts whose current validity is difficult to determine for non-expert readers.4 Slovenia will similarly require consolidation following the Constitutional Court's recognition (in October 2024) of discrimination in access to techniques, as identified by the Advocate of the Principle of Equality.5 Switzerland has acknowledged this need and recently updated its MAR legislation.6 Moreover, in other countries such as North Macedonia, Spain and Belgium, we identified regulatory gaps that generate legal uncertainty regarding practices such as ROPA (Reception of Oocytes from Partner) and social freezing.

The comparative analysis showed that European MAR legislation, despite its fragmentation, falls into two broad categories. In one group, the use of MAR is linked to the treatment of medical infertility (Italy, Slovenia, Albania, Kosovo), whereas in the other group, it is linked more closely to personal autonomy (Spain, Belgium, North Macedonia, and, recently, Switzerland). Countries of the first group restrict access to MAR to circumstances in which human reproduction would be possible if no fertility problems existed (heterosexual couples), whereas countries of the second group recognize a more or less universal right to access.

Shared understanding of what is misleading advertising

In contrast to MAR legislation, there is no significant difference in the normative regulation of advertising between EU countries and non-EU countries. As a result, information presented by the online advertising of clinics must comply with similar parameters in all the countries analyzed.

The general regulations for advertising have a common origin in the Directives of the European Union and in the ICC Advertising and Marketing Communications Code of 2018. The EU countries examined in this study (Belgium, Spain, Italy and Slovenia) are required to comply with EU Directives on unfair competition, misleading advertising, content sharing platforms, and protection of personal data. The non-EU countries examined (Albania, Kosovo, Macedonia and Switzerland), although not obliged to comply with the EU Directive, have voluntarily assumed compliance with the Consumer Protection and Competition Directive, in some cases through the signing of status agreements between the EU and the country in question (e.g., Albania). Others (e.g., Northern Macedonia), after joining the World Trade Organization (WTO), have signed stabilization and association agreements with the EU for the harmonization of the country with EU regulations with the aim of progressive integration into the EU market. In the case of Kosovo, voluntary compliance with EU directives is affected by the adoption of consumer protection regulations (Table in Annex).

Thus, regardless of differences between EU countries and non-EU countries, all of the countries analyzed have adopted common EU regulations for misleading advertising as domestic law, either through unfair competition laws (as is the case for Spain, Belgium and Switzerland) or through consumer protection laws (such as Albania, Slovenia, Macedonia, Kosovo). Consequently, in general, the same advertising principles apply in all the countries analyzed.

In addition, the EU member countries that have established self-regulatory systems for advertising have their own Advertising Self-regulation Body: Audiovisual Media Authority (AMA) in Albania; Autocontrol in Spain; Jury d'Ethique Publicitaire (JEP) in Belgium; Slovenian Advertising Chamber (SOZ); Istituto dell'Autodisciplina Pubblicitaria (IAP) in Italy; Schweizerische Lauterkeitskommission (SLK) in Switzerland. Consumers in these countries can manage cross-border advertising disputes through the European Advertising Standards Alliance (EASA). This allows any consumer in the European Union to submit a matter to the competent advertising self-regulation body abroad through the homologous body existing in their own country.

These regulatory bodies have also approved specific deontological codes for regulation of advertising practices (e.g., the Albanian Code of Broadcast −2014-, the Spanish Advertising Conduct Code −1996-, the Italian Code of Marketing Communication Self-Regulation −1966-, or the Swiss Principles of Integrity in Commercial Communication −2022), all of which are inspired by the Code of the International Chamber of Commerce for Advertising and Marketing Communications of 2008. These deontological codes collect in detail the principles for truthful advertising that are contained in the various regulations of each state.

There is, therefore, greater regulatory homogeneity in the field of commercial information, although there is no sectoral code at the European level that regulates this issue in the area of MAR. Consumers benefit from these various kinds of legislation and self-regulation and can report advertising campaigns that violate legal or ethical standards. All the information for international users must respect the same ethical and legal principles.

A truthfulness requirement is contained in the EU Directive on misleading advertising and in the advertising regulations and principles of all countries. It obliges clinics to avoid any type of misleading advertising that could deceive recipients of this information. The regulations of all countries maintain the same criteria for misleading advertising in the following cases: a) false information about the elements essential to making an accurate judgment about the service or treatment being offer ed; b) information that, although true, is presented in an inappropriate and misleading way; and c) the absence of essential information.

Misleading advertising is considered an unfair practice of the company—in this case, the clinic—and to avoid it, some laws (eg. Switzerland Federal Law Against Unfair Competition, 1986) impose the burden of proof on the advertiser with respect to the veracity of the data contained in their advertisements.

Information provided by assisted reproduction clinics

This section presents the findings of our analysis of information provided on the websites of assisted reproduction clinics. The focus is on elements previously identified as essential for safeguarding informed consent and, consequently, patient autonomy. To enhance clarity, the results are organized under five subheadings corresponding to the main areas of analysis: success rates, associated risks, scientific evidence regarding treatments (including add-ons), and the legal and ethical dimensions of these practices. This structure aims to provide a comprehensive and systematic overview of the reality observed in clinic communications, complementing the normative analysis presented in Sect. "Normative framework of medically assisted reproduction techniques and commercial information: General overview and key findings".

Success rates

The thematic analysis conducted within the B2-InF project reveals a heterogeneous landscape in the presentation of success rates. While most clinics include references to success rates on their websites, the nature, clarity, and reliability of this information vary considerably.

Success rates are frequently used as promotional tools, often without standardized definitions or methodological transparency. Clinics tend to associate success with fertilization, pregnancy, or live birth, but rarely specify which outcome is being measured. For instance, Hygeia Hospital in Albania [19] claims a 65% success rate, yet does not clarify whether this refers to fertilization, clinical pregnancy, or live birth. IVI Clinic in Italy reports a 99% success rate for oocyte donation treatment after three cycles, and although it breaks down success rates by technique used, it is impossible to determine what is meant by 'success'—whether it refers to a positive pregnancy test or to a live birth [20]. Furthermore, our research revealed a significant disparity between the 65.1% success rate reported by the Instituto Bernabeu (Spain) and the 28% success rate reported by the Maribor Clinic (Slovenia) for the same technique (in vitro fertilization with an embryo not subjected to cryopreservation) [20, 21].

Age is consistently identified as the most influential factor affecting ART outcomes. GENERAROMA Clinic (Italy) provides stratified data showing a decline in full-term pregnancy rates from 42% in women under 35 to just 4% in women over 43 [22]. Brussels IVF Clinic (Belgium) reports that results for women under 36 years of age indicate that “47% of women starting IVF-ICSI give birth after their first treatment cycle”. After the third treatment cycle, “74% will have given birth.” The treatment's success rate drops significantly as the age of the prospective parent rises (> 36 years) delivery rates of 50% for women under 37 undergoing artificial insemination (AI), and 61% for those using donor sperm (AID), with significantly lower rates for older women [23].

Some clinics offer cumulative success rates over multiple cycles, while others present per-cycle probabilities. RAPRUI Clinic (Italy) reports a cumulative figure as a 'success rate': 1,779 children born at the center [24], whereas CHIREC Clinic (Belgium) notes that over 60% of recipients of oocyte donation become pregnant after three transfers [25]. In North Macedonia, Remedika Clinic presents age-specific data, indicating a 70% positive pregnancy test rate for women under 31 and only 15% for those over 40 [26].

Despite these figures, many clinics fail to distinguish between biochemical pregnancy, clinical pregnancy, and live birth, leading to potential misinterpretation. Moreover, comparisons to natural conception are occasionally made without supporting data, as seen in New Born Clinic (North Macedonia), which claims IVF success rates are higher than natural pregnancy, yet reports a live birth rate of 26% compared to 30% for natural conception. [27]

In some cases, clinics acknowledge the limitations of generalized success rates and offer individualized assessments during consultations. Brussels IVF Clinic, for example, emphasizes the importance of tailoring expectations based on medical history and prior outcomes [28]. Instituto Marqués provides the possibility of tracking results individually through its Embryoscope program (a time-lapse incubator system that allows patients to view their embryos' development in real-time) [29].

In cases where the distinction is made, the data for success rates are frequently given in terms of pregnancy and rarely in terms of live birth, without any mention of the significant difference between these two measures of success [29]. Some clinics claim that their success rates are monitored by national and European institutions and use this information to compare themselves favorably with other European clinics in terms of success rates but without giving specific figures [30, 31].

Others clinics do not explicitly state 100% success rates, but imply them when they guarantee a result within a specific timeframe, such as “The Security of a Happy Future: A clear horizon—up to 30 months to become parents” -Garanzia di nascita' (Birth Guarantee) Program- [22] or “Pregnancy Guarantee or Money-Back Program” [32].

Given the considerable variability and lack of standardized definitions observed, it becomes extremely difficult—if not impossible—for prospective patients to construct a clear and reliable understanding of their actual chances of success. This situation does not align with the standards governing commercial information, which require that individuals be able to form an adequate and accurate picture of the essential elements before entering into a contractual relationship.

Risks associated with MAR

Information on risks associated with ART treatments is generally limited and unevenly presented. Regarding maternal risks, while most clinics acknowledge their existence, the depth and specificity of the information provided vary considerably across sources. More critically, information concerning risks to the newborn is virtually non-existent. When newborn health is addressed, it is invariably presented in terms of these techniques serving as tools to guarantee or enhance the health of the conceived child, rather than acknowledging potential risks [22].

The most frequently mentioned risks include miscarriage, multiple pregnancies, and ovarian hyperstimulation syndrome (OHSS). Miscarriage is often linked to maternal age, with older women facing higher probabilities of pregnancy loss. OHSS is described as a rare but serious complication, occurring in approximately 1–5% of IVF or IVF-ICSI cycles. Clinics such as Kopelli and CHIREC provide detailed descriptions of OHSS, noting its unpredictability and the importance of updated stimulation protocols to mitigate its occurrence [25, 33].

Hormonal treatments are also associated with a range of side effects, including mood swings, headaches, breast tenderness, water retention, and in rare cases, thrombosis. These effects are typically described as mild and manageable, though their mention is not universal across clinic websites.

The psychological impact of ART is addressed by several clinics, which highlight the emotional burden of treatment and offer psychological support services. This includes individual counseling, group therapy, and stress management interventions, aimed at improving patient well-being and potentially enhancing treatment outcomes.

Information regarding risks to newborns conceived through ART is notably scarce. Two clinics address this issue directly: one asserts that ART-conceived children are not at increased risk of disease, while another notes that birth weights may differ—being either lower or higher—compared to those conceived naturally. However, no clinic provides detailed data or references to long-term studies on child health outcomes.

The analysis shows that risk information is often incomplete, fragmented, or presented in general terms without quantifying probabilities or differentiating between short- and long-term effects. Some clinics mention common complications, such as ovarian hyperstimulation syndrome, but rarely provide data on incidence or severity. Others omit risks altogether or frame them in reassuring language without scientific backing.

Therefore, given this lack of specificity and transparency, patients cannot realistically assess the potential health implications of MAR procedures. This falls short of the standards requiring that essential information be provided in a way that enables informed and prudent decision-making.

Add-ons and non-evidence.based treatments

Information about additional treatments not supported by scientific evidence is offered by practically all of the clinics analyzed [22, 27, 34]. Among these, PGT-A (also referred to as PGD or preimplantation genetic diagnosis) is the most frequently mentioned.

Clinics offering PGT-A often present it as a strategy to improve success rates or reduce miscarriage risk, especially in older patients or those with a history of implantation failure. For example, one clinic claims that PGT-A reduces miscarriage rates to below 10%, regardless of maternal age. However, such claims are rarely accompanied by references to clinical guidelines or peer-reviewed evidence, and the potential limitations or controversies surrounding these techniques are not addressed.

The analysis highlights that none of the clinics explicitly acknowledge the lack of consensus in the scientific community regarding the effectiveness of these add-ons. Moreover, there is no mention of regulatory warnings or recommendations, such as those issued by the UK’s Human Fertilisation and Embryology Authority (HFEA), which classifies PGT-A as an add-on with limited evidence of benefit for most patients [35].

References to scientific evidence are sporadic and often limited to generic statements such as “clinically proven” or “supported by research,” without citing sources or explaining the level of evidence. In some cases, clinics refer to international guidelines but do not indicate whether their protocols adhere to them.

Consequently, the absence of verifiable and contextualized evidence makes it difficult for users to evaluate the reliability of the treatments offered, which undermines the principle that commercial information should allow a clear and accurate understanding of the essential elements of the service.

Legal information

In general, the information provided by clinics is in line with the normative regime for the use of MAR techniques. However, exceptional situations have been identified where this is not the case, either because the information provided does not comply with the law or because the existence of a legal loophole is exploited to present a practice as normative behavior.

For example, two of the Belgian clinic websites analyzed refers to surrogacy in a manner that creates the false belief that the contract is legal and binding [36]. However, Belgian law stipulates that the “author of a parental project”7 is the user of the technique and should be considered the legal mother. Surrogacy dissociates the user from the author of the parental project so that the user of the techniques lacks the title to determine the filiation of the child in her favor, without Belgian legislation authorizing that dissociation, since it does not contemplate that the techniques be used in a different person from the "author of the parental project" and determines parentage in favor of the woman giving birth (art. 315 of the Belgian Civil Code).

Additionally, information that is not in accordance with the law can generate the impression of having obligations that one does not have (e.g., contracting the service of the ROPA to become co-mothers in Spain8) or hide legal problems that could arise in the future (e.g., in cases of same-sex coparenting, information should be provided on the domestic rules regarding the determination of parenthood).

Overall, the information provided by clinics is broadly consistent with the applicable legal framework. However, certain exceptions were identified. These gaps may hinder a comprehensive understanding of the regulatory context, even though the general alignment with legal standards remains evident.

Ethical issues

The analysis reveals that clinics across the eight European countries studied vary considerably in how they address ethically sensitive topics. While most clinics include some reference to ethical considerations, the depth and transparency of this information are inconsistent.

One of the most frequently discussed ethical issues is donor anonymity. Several clinics acknowledge the legal frameworks governing gamete donation, including restrictions on the disclosure of donor identity. For example, clinics in Italy and Albania note that donors cannot be known to the recipient couple, and that no identifying information may be shared, even in cases of medical necessity. However, the potential ethical dilemmas arising from this anonymity—such as the child’s right to know their genetic origins—are not mencioned.

Another recurring theme is the restriction of access to MAR based on marital status or sexual orientation. In countries like Italy, clinics explicitly state that ART treatments are legally limited to heterosexual couples, excluding single women and same-sex couples. While some international clinics offer services abroad to circumvent these restrictions, the ethical implications of such limitations are not critically examined.

Clinics also touch upon the ethical complexity of embryo-related procedures, including embryo freezing, biopsy for genetic analysis, and embryo donation. Some websites acknowledge that patients may experience moral conflict when deciding whether to analyze embryos genetically or to freeze surplus embryos. In Switzerland, the legal status of surrogacy is highlighted as a source of ethical and legal tension, particularly regarding the determination of legal parenthood [37].

Notably, none of the clinics systematically address broader ethical debates surrounding MAR. Ethical concerns are generally framed as individual dilemmas rather than structural or policy-level issues. Accordingly, the omission of substantive ethical information hinders the ability of individuals to evaluate the broader implications of their choices, which is inconsistent with standards requiring transparency on elements essential for informed consent and contractual decision-making.

Discussion

Our analysis yielded two sets of findings:

Regulatory framework and advertising rules: European MAR legislation remains fragmented, with two main approaches—one linking access to medical infertility and another emphasizing personal autonomy. By contrast, advertising regulation is largely homogeneous across the countries analyzed, as all clinics must comply with EU rules on misleading advertising and consumer protection, which have been transposed into national laws, even though there is no sector-specific code for MAR.

Information provided by clinics: Websites show significant variability in clarity and completeness. Regarding the aspects identified as essential for contracting clinic services, success rates are widely reported but lack standardization and often fail to distinguish between pregnancy and live birth, which prevents users from forming a realistic understanding of their chances of success. Risks—especially for newborns—are scarcely addressed, and add-ons such as PGT-A are promoted without acknowledging scientific controversy. Legal information is sometimes inaccurate or misleading (e.g., ROPA in Spain, surrogacy in Belgium), creating potential confusion for patients. Ethical issues are rarely accompanied by warnings about the problematic nature that the use of certain techniques may entail from an ethical perspective.

Current legal and ethical landscape

Research in the legal and medical literature examining how assisted human reproduction clinics advertise the fundamental aspects necessary for potential patients' decision-making remains very limited and practically restricted to success rates. The Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom conducted an analysis of promotional information within the reproductive medicine sector and identified a concerning lack of transparency in the presentation of success rate statistics, advocating for percentages to be displayed as "live birth rate per embryo transfer" [38]. Similarly, an examination of websites from over 90% of U.S. clinics revealed that, according to American Society for Reproductive Technology (SART) advertising guidelines, live birth rates per cycle start (intended retrieval) must be displayed prominently first, followed by rates per egg retrieval and per embryo transfer, with success rates categorized by SART-defined age groups [12]. The omission of live birth data per cycle start is explicitly prohibited.

In our view, however, the information provided to users of these techniques must go beyond mere success rates, despite the fact that scientific literature has largely concentrated on this aspect of information disclosure [39]. It is therefore crucial to assess whether the information made available offers a comprehensive and balanced understanding of the key elements involved in the provision of assisted reproduction services.

Overall, the findings suggest a need for greater transparency and standardization in the communication of ART-related risks. Clinics should aim to provide clear, evidence-based information not only on immediate medical risks but also on potential long-term outcomes for both patients and offspring. Additionally, it is essential that patients are informed about the level of scientific evidence supporting the recommended treatments, enabling them to understand the degree of certainty or uncertainty underlying different therapeutic options. This would support informed decision-making and align clinical practice with ethical standards of patient care.

The absence of critical information raises concerns about the transparency and ethical standards of patient communication. The promotional framing of such procedures may contribute to unrealistic expectations and unnecessary financial burden, particularly when these interventions are offered as optional upgrades without clear justification.

Furthermore, a critical gap thus exists between the complexity of these ethical debates within academic discourse and the type of information typically made available to patients seeking assisted reproductive services.9

This informational deficit constitutes a fundamental breach of patients’ rights to comprehensive disclosure concerning the services they are acquiring. Patients are entitled to be informed about all relevant aspects of the procedures they are undertaking, including potential ethical concerns. It is plausible that many individuals simply do not anticipate the ethical dilemmas involved; for this reason, it is the responsibility of clinics to proactively inform them —not about the full complexity of these dilemmas, but rather about the fact that certain procedures or the use of specific techniques may raise ethically problematic issues.

Contemporary academic discourse in English-speaking contexts highlights the complexity and evolving nature of these ethical challenges, particularly as technological developments continue to outstrip both regulatory frameworks and patient comprehension. Each of these reproductive technologies gives rise to distinct ethical dilemmas that most patients are unlikely to foresee in the absence of adequate counseling.

In the case of preimplantation genetic diagnosis (PGD), recent scholarship has highlighted a disconnect between academic debate and clinical realities, pointing to the need for more grounded ethical frameworks. Current discussions focus on expanding applications beyond traditional genetic disease prevention to include HLA-matching for existing siblings, late-onset disease screening, and even non-medical sex selection [40]. Contemporary ethical considerations encompass not only the moral status of the embryo and parental duties, but also broader social policy questions regarding access and the technology's impact on families, women, and medical practice[41]. The debate has intensified around what constitutes acceptable grounds for embryo selection, with scholars grappling with the implications of using genetic testing for increasingly nuanced medical conditions and predispositions that patients may not fully comprehend at the time of consent.

Surrogacy presents equally complex ethical terrain in current academic discourse. Recent analyses frame the debate around competing paradigms of empowerment versus oppression, examining physical, psychological, and psychosocial health risks to surrogates alongside questions of maternal rights and children's welfare. The academic community continues to grapple with fundamental questions about bodily autonomy and dignity, particularly in commercial arrangements. Contemporary critics argue that surrogacy risks commodifying women's bodies and reducing pregnancy to a mere transaction [42], while proponents emphasize reproductive autonomy and the potential for mutually beneficial arrangements. Recent scholarship has also challenged the medical framing of surrogacy entirely, arguing that it constitutes a socio-legal rather than medical intervention, which has significant implications for how such practices should be regulated and ethically evaluated [43]. Patients embarking on surrogacy arrangements rarely receive adequate preparation for the complex emotional, legal, and ethical relationships they will navigate throughout and beyond the pregnancy.

Donor conception exemplifies this problematic disconnect between social normalization and inadequate ethical preparation. While donor gamete procedures have become increasingly mainstream and socially accepted, current academic discourse reveals significant unresolved ethical and psychological complexities that patients rarely anticipate. The issue of genetic identity and its psychological implications for both parents and resulting children remains contentious. Recent scholarship explores the long-term psychological effects on parents who must navigate the complex emotional terrain of raising genetically unrelated children, including issues of disclosure, family narrative construction, and the management of dual parental identities [44]. The rights and welfare of donor-conceived individuals present ongoing ethical challenges that extend far beyond the initial treatment period, particularly with respect to the growing movement for the abolition of donor anonymity, driven by donor-conceived adults seeking genetic and medical information about their biological origins [45]. Additionally, commodification concerns surrounding gamete donation continue to generate substantial academic debate about how market-based approaches may compromise the voluntary and altruistic foundations traditionally considered essential to ethical donation practices [46].

Social egg freezing presents perhaps the most complex intersection of individual choice and systemic social pressures. Contemporary bioethicists and policy-makers remain divided as opponents argue that social freezing is not an adequate response to the growing socioeconomic constraints that lead women to postpone motherhood. While proponents argue that social egg freezing could serve as a tool to expand reproductive autonomy and promote gender equality by enabling responsible biographical planning, critics contend that this technology places the burden of adaptation on individual women rather than addressing the structural inequalities that create impossible choices between career advancement and family formation [47].

The ethical debate surrounding nonmedical egg freezing raises familiar concerns about the limits of individual autonomy when medical technology is used for elective purposes. However, the deeper ethical concern lies in how social egg freezing may inadvertently reinforce workplace cultures and economic systems that remain fundamentally incompatible with women's reproductive lives. Rather than challenging employers to provide adequate parental leave, childcare support, or flexible career trajectories, social egg freezing risks normalizing the expectation that women should undergo medical interventions to accommodate inflexible professional demands. This technological solution may, in fact, perpetuate gender inequality by implying that the problem lies in women's biology rather than with social and economic structures that fail to support work-life integration [48].

The academic discourse reveals that while these reproductive technologies have achieved varying degrees of social acceptance, the underlying ethical tensions remain unresolved and continue to generate unexpected challenges for individuals and families long after treatment completion. This disconnect between social normalization and ethical complexity underscores the need for comprehensive pre-treatment counseling that addresses not only medical risks but also the potential long-term ethical, psychological, and social implications of treatment choices. The failure of clinics to provide adequate information on these dimensions constitutes a significant ethical breach that undermines informed consent and patient autonomy.

Limitations

This study is subject to several limitations that should be considered when interpreting the findings. First, the analysis is limited to eight European countries selected for participation in the B2-InF project. These countries were chosen to capture diversity in legal, institutional, and socio-cultural contexts, rather than to achieve proportional or statistically representative coverage of all European ART clinics. The results should therefore be understood as illustrative of broader patterns and inconsistencies in clinic communication practices, rather than as generalizable to the entire European landscape.

Second, the exhaustiveness of the analysis varied across countries depending on the number of fertility clinics operating in each jurisdiction. For instance, Slovenia has only three clinics, whereas Italy and Spain have hundreds. Consequently, the representativeness of the sample varies accordingly.

Third, although one of the original aims was to assess compliance with informed consent regulations, only Italian and Slovak clinics make their consent forms publicly available. This prevented a comprehensive analysis of informed consent practices across all countries studied. We note that informed consent documents should be publicly accessible to anyone who wishes to consult them.

Finally, regarding the relevant normative frameworks, the small volume of complaints at the European level has resulted in limited case law on the matters under analysis, which constrains the depth of legal assessment possible.

Despite these limitations, the recurrent deficiencies identified across diverse contexts point to structural issues in the regulation and communication of ART information. By revealing these patterns, the study contributes to the broader discussion on transparency, patient rights, and the need for harmonised ethical standards in assisted reproduction practices across Europe.

Wider implications

Given the rapid growth of the fertility treatment industry and the findings of this study, there is no doubt that European legislators will have to pay more attention to the regulation of commercial activity surrounding MAR. With respect to advertising, for example, we should expect the regulation of fertility clinics to follow a trajectory similar to that of advertising in other sectors, such as medicine, tobacco, tourism, alcohol, games, financial advertising, and tourist contracts.

However, clinics have the possibility of anticipating legislative reforms by adopting self-regulatory measures. Organizations for the self-regulation of advertising in certain sectors exist in almost all the countries examined. In light of the success of these sectoral advertising codes, clinics could follow their example by coordinating the development of codes for MAR advertising. In this case, the regulation of advertising activity would depend in part on the clinics themselves through the development of commercial communication policies and the establishment of adequate procedures to protect the legitimate interests of the clientele. Moreover, the adoption of a self-regulatory regime guarantees early correction of inappropriate behavior.

Conclusions

From the analysis gathered in the preceding pages, and considering the differences identified between normative regulation and the information currently available on clinic websites, we propose a series of recommendations aimed at enhancing the quality of information and promoting closer alignment with regulatory standards. These recommendations should guide clinics when designing their commercial information strategy.

Before these recommendations are presented, it is appropriate to note that, in general, it is recommended that the clinics themselves promote sectoral regulation of the commercial information they offer to society through their websites.

Clear information on success rates and associated risks

With respect to success rates, the analysis underscores the need for greater transparency and standardization in the communication of ART success rates. Clear definitions, age-specific data, and distinctions between outcome types are essential to ensure that prospective patients receive accurate and meaningful information. From this viewpoint, the following recommendations are proposed:

• 1. The clinics should avoid the use of imprecise or misleading expressions and limit themselves to objective data on the basis of the best available evidence.

• 2. Clinics should clearly define the success rate as the probability of having a healthy child rather than the probability of fertilization or clinical pregnancy.

• 3. Clinics should base information about success rates themselves on verifiable statistics and mention the source for these data.

• 4. Clinics should provide a link or website where the aforementioned data are made available for possible verification.

• 5. Clinics should avoid making comparisons with success rates of other clinics unless this information is specific, objective, and supported by verifiable data that are made available.

With regard to associated risks, the following is recommended:

• 1. Clinics include information about risks on all websites.

• 2. Information about risks should be objectively determined without subjective assessments that minimize their significance (for example, by suggesting that risks are negligible compared to the value of becoming a parent) or that inappropriately attribute risks primarily to women's behavior rather than to the procedures themselves.

• 3. When presenting information about associated risks, the language used should be technical and precise, accurately qualifying the type of risk and its probability.

• 4. Information about risks should include the psychological risks associated with treatment.

• 5. Risks related to the embryo, perinatal, and postnatal health of the child must also be specified.

No commercial information about add-on treatments

Owing to the lack of scientific evidence about add-on treatments, their use should be recommended only on the basis of a clinical trial [17]. Regulations that can be applied by analogy, such those that apply to advertising by dentists in Spain, consider advertising “that refers to treatments whose preventive or therapeutic effects are not supported by sufficient technical scientific evidence” [49] to be directly misleading and, therefore, explicitly prohibited. At the very least, potential patients should be informed of the lack of scientific evidence concerning the efficacy of add-on treatments. Wherever efficacy is claimed, clinics should provide access to evidence-based sources of data on add-ons for purposes of verification.

Another important guideline is that information about add-ons provided through websites and advertising should match the information provided through informed consent [50].

Clear information about the normative regulation of procedures and its ethical implications

Special attention should be given to procedures such as PGD, the ROPA method, and social freezing, which either lack specific regulatory frameworks or involve practices that may not be fully aligned with existing legal regimes in certain jurisdictions. Similarly, information about surrogacy arrangements requires particular caution, especially in contexts where their legal validity remains ambiguous or contested. For all these procedures, clinics should ensure that the information provided clearly addresses both the legal status of the treatment in the relevant country and the ethical considerations involved. In cases where normative guidance is limited, we recommend that clinics refer to reports and recommendations issued by national Bioethics Committees in their respective countries, which can provide valuable ethical frameworks for patient counseling.

Moreover, while ethically sensitive topics are present in the informational landscape of ART clinic websites in the countries analyzed, their treatment tends to be superficial and primarily focused on legal compliance rather than ethical reflection. There is a clear need for more comprehensive and thoughtful communication that not only informs patients about legal requirements but also acknowledges the moral complexity of reproductive technologies, thereby supporting truly informed decision-making that respects both legal standards and patients' ethical values.

We expect a growing level of awareness among authorities regarding the importance of compliance with the regulation of MAR, as well as a growing complexity of regulatory contexts. To achieve compliance with regulatory requirements and to lower the risk of infringement, as well as to increase transparency and avoid foreseeable damage to the reputation of clinics, we suggest that the sector take a proactive stance that demonstrates its willingness and concern to comply with regulations. Clinics should take the initiative to support the public’s right to information by voluntarily adopting good practices.

Abbreviations

AMA

Audiovisual Media Authority, Malta

AUTOCONTROL

Spain

B2-InF

Be better informed about Fertility

EASA

European Advertising Standards Alliance

ECtHR

European Court of Human Rights

ECvHR

European Convention on Human Rights, opened for signature 4 November 1950, 213 UNTS 221 (entered into force 3 September 1953)

EFTA

European Free Trade Association

IAP

Istituto dell'Autodisciplina Pubblicitaria, Italy

IUI

Intrauterine insemination

IVF

In Vitro Fertilization

JEP

Jury d'Éthique Publicitaire, Belgium

MAR

Medically assisted reproduction

PGD

Preimplantation genetic diagnosis

ROPA

Reception of Oocytes from Partner

SLK

Swiss Commission for Fair Trading

SOZ

Slovenian Advertising Chamber

WTO

World Trade Organization

Authors’ contributions

M.A. led the study design, conducted the normative analysis, drafted the initial manuscript and oversaw all subsequent revisions, including responses to reviewers and editors and preparation of the final version. R.T. and J.F. Conducted the normative data collection and normative analysis A.V. Revised the paper during the pre-publication process and compiled the literature. S.M. Supported the normative analysis, and refined the manuscript by incorporating recent research. J.M.C. and M.T.L. Supervision and formal analysis of normative data of clinics Websites A.B. and M.F. Conducted normative data collection of clinics Websites N.B. Provided overall supervision and substantively revised the main manuscript text. F.G. Led the design of the study, provided overall supervision and mentorship to ensure the quality and integrity of the research and funding acquisition.

Funding

This project has received funding from the European Union’s Horizon 2020 research and innovations programme under the grant agreement No.872706.

Data availability

All data and materials are available on DOI [https://zenodo.org/communities/b2inf\_h2020/] . This project contains the following extended data: —National guidelines for each country —Global recommendation guidelines —Policy briefs for each country —Global policy brief —Project communication (e.g. newsletters, flyers, conference posters…) —Research project documents (e.g. reports, checklists, handbooks for data collection…) —Scientific publication Some data cannot be shared due to confidentiality constraints, as access has been restricted given the sensitive nature of the information provided. There is a concern that the fertility industry might exploit this information for commercial purposes. Therefore, in the Grant Agreement nr. 872,706 — B2-InF, signed by the Research Executive Agency of European Commission and all B2-InF project partners, was established that the dissemination level of the interviews, as well as the dissemination level of the reports and thematic analyses of the interviews, is "confidential", explicitly defined as "only for members of the consortium (including the Commission Services)". (see Annex 1, p. 6/27 of the Grant Agreement nr. 872,706). To request access, please email the corresponding author. Access will be granted once is confirmed that the data will be used solely for scientific research purposes and that all researchers involved in the study have no conflicts of interest.

Declarations

Ethics approval and consent to participate

This project (n° 2021.004) received ethical approval on 29 January 2021 from the Research Ethics Committee of Navarra University. Procedures involving human participants or human data were conducted in accordance with the ethical standards of the institutional and national research committee and with the principles of the Declaration of Helsinki (as revised in 2013).

Written informed consent was obtained from all participants prior to their inclusion in the study. Participants received clear and accessible information about the purpose of the study, the procedures involved, the use of their data, and confidentiality safeguards. Consent was given voluntarily and participants were informed of their right to withdraw at any time without any consequences.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.