Infertility, Reproductive Equity, and Policy Pathways for Assisted Reproductive Technology in the Democratic Republic of the Congo

Abstract

Background

Infertility affects an estimated 1 in 6 adults worldwide, yet access to assisted reproductive technology (ART) remains highly inequitable, underscoring the need for policy action. The Democratic Republic of the Congo (DRC) constitutionally recognizes reproductive rights and ART. However, public ART services are virtually nonexistent, highlighting a critical gap in reproductive health services.

Methods

We conducted a mixed‑methods study combining quantitative analysis of 146 women presenting for infertility care at Elikya Clinic (Kinshasa, 2020–2024) with a normative review of Congolese law and international standards. Associations between categorical variables and infertility type (primary vs secondary) were tested with the chi‑square test; binary logistic regression produced crude and adjusted odds ratios (COR, AOR) with 95% confidence intervals (CI), ensuring robust evidence to inform policy decisions.

Results

Primary infertility was observed in 51.4% (n=75) of women and secondary infertility in 48.6% (n=71). Loss to follow‑up after referral for ART occurred in 30.8% of referred women. In adjusted models, tertiary education (AOR = 2.58, 95% CI: 1.07–6.23), alcohol consumption (AOR = 2.45, 95% CI: 1.07–5.10), and referral loss (AOR = 3.20, 95% CI: 1.24–8.26) were independently associated with secondary infertility. Obesity was common (54.1%) but did not remain significant after adjustment.

Conclusion

While the DRC’s legal framework recognizes medically assisted procreation, the lack of public ART infrastructure and regulation highlights opportunities for meaningful reform. Policy actions can improve reproductive health equity and align with human rights commitments.

Plain Language Summary

Many people in the Democratic Republic of the Congo struggle with infertility, but treatment options are limited. Although the country’s laws recognize the right to fertility care, in practice, only wealthy families can afford Assisted Reproductive Technologies like In clinical fertilization, which are offered in private clinics. This study looked at 146 women in Kinshasa and found that infertility is common, often associated with obesity and alcohol use, and that many women are lost to follow-up when referred for treatment. The research shows a big gap between what the law promises and what women actually experience. To make fertility care fair and accessible, the government would need to provide public clinics, include infertility treatment in health coverage, and ensure safe, regulated services. Infertility is not just a medical issue, it affects women’s rights, family life, and social equality.

Introduction

Infertility has emerged as a pressing global public health concern. Recent estimates from the World Health Organization (WHO) indicate that approximately one in six adults worldwide experience infertility during their lifetime, with prevalence rates comparable across high-, middle-, and low-income countries.¹ The burden of infertility extends beyond biomedical dimensions, encompassing profound psychological distress, marital instability, and social stigma. In societies where parenthood influences identity and social status, infertility can marginalize women and create gender disparities.²

Advances in Assisted Reproductive Technology (ART), including in clinical fertilization (IVF) and related interventions, have transformed the landscape of reproductive health by offering new pathways to parenthood. However, access to ART remains highly inequitable While high-income countries increasingly integrate ART into their health systems, low- and middle-income countries face structural barriers, including limited availability, prohibitive costs, and weak institutional frameworks. This global disparity raises critical questions of reproductive justice: how can reproductive rights be meaningfully realized when access to fertility care depends on economic and geographic lines^3,4?

In Sub-Saharan Africa, infertility prevalence is particularly high, with systematic reviews reporting rates of up to 30–40%.⁵ Despite cultural norms that valorize high fertility, infertility is often met with silence and stigma, leaving affected individuals with limited medical or psychosocial support. Women, in particular, bear the brunt of these consequences, facing exclusion, marital instability, and even violence. The Maputo Protocol, ratified by many African states, explicitly obligates governments to ensure access to comprehensive reproductive health services, including fertility care.^6,7 However, implementation remains uneven, reflecting broader challenges of health system capacity and prioritization.

The Democratic Republic of the Congo (DRC) presents a paradoxical case. With an average fertility rate of 6.6 children per woman,⁸ infertility is often overlooked and under-documented, its magnitude obscured by the country’s demographic profile.⁹ Nevertheless, for couples experiencing childlessness, the consequences are profound. The Congolese Constitution (Articles 14 and 53) and Law n° 18/035/2018 formally recognize reproductive rights and ART.¹⁰ However, the absence of state-run ART centers highlights a critical gap between legal recognition and practical implementation. In this context, reproductive rights risk remaining aspirational rather than actionable, accessible only to those who can afford private, often costly, services.

The objective of this study is to assess the characteristics of women seeking infertility treatment in Kinshasa, including the proportion referred for ART and those who were subsequently lost to follow-up. By situating infertility within both global and Congolese contexts, the study underscores the urgent need for equitable access to reproductive technologies in the DRC. Addressing infertility requires a multifaceted approach that extends beyond medical intervention. Issues of social justice, human rights, and gender equity, while globally resonant, demand context‑specific responses within the Congolese health system and remain central to any comprehensive strategy for equitable reproductive care.

Methods

Study Design

The study used an integrated design, combining a retrospective cross-sectional quantitative analysis with a normative legal and ethical review. The quantitative component analyzed clinical records of women seeking infertility care. The normative component reviewed Congolese laws, international frameworks, and ethical principles governing reproductive health and assisted reproductive technologies. This approach follows established precedents in health‑services research, where quantitative facility or patient data are interpreted alongside legal and policy analysis to assess implementation gaps and normative obligations.^11–13

Quantitative Component

Data Source and Sampling

This retrospective, single‑center study was conducted at Elikya Clinic in Kinshasa, DRC, a specialized facility providing gynecological and reproductive health services. Although the single‑center design and retrospective data collection limit the generalizability of findings to other settings, particularly rural areas with limited reproductive health infrastructure, the clinic serves a diverse patient population from across Kinshasa and its environs, making it a suitable site for an initial investigation of infertility care patterns in the DRC. The cross‑sectional nature of the data precludes causal inference, and several limitations should be noted: incomplete information on specific causes of infertility, partners’ fertility status, and socioeconomic characteristics constrained the analysis. Moreover, the “loss‑to‑follow‑up” outcome may encompass multiple scenarios, including continuation at alternative facilities, treatment discontinuation, or financial barriers that could not be delineated within this dataset due to data unavailability in private clinics. Consequently, while the normative legal and ethical review provides an interpretive framework for understanding these findings, the analysis necessarily involves contextual judgment.

The study population comprised all women of reproductive age who presented with a diagnosis of infertility, defined according to WHO criteria as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse,¹⁴ and who sought care at Elikya Clinic between January 2020 and December 2024. The classification of infertility followed standard clinical definitions, categorizing it as primary (absence of prior pregnancy) or secondary (prior pregnancy irrespective of outcome).¹⁵

Eligibility criteria for inclusion were: (a) female patients aged 15–49 years at the time of consultation; (b) a documented diagnosis of primary or secondary infertility; (c) complete medical records containing the socio-demographic, clinical, and referral variables of interest; and (d) a first consultation for infertility during the study period to avoid duplicate counting of the same patient across multiple visits. Exclusion criteria were: (a) incomplete or illegible medical records precluding data extraction; (b) male-factor infertility as the sole identified cause (as these patients were typically referred directly to urology services); and (c) duplicate entries for the same patient.

A total of 730 gynecologic consultations were documented during the study period. After applying eligibility criteria and removing duplicate or incomplete records, 146 unique infertility cases met the inclusion criteria. This complete enumeration, representing approximately 20% of all gynecologic consultations, was chosen over random sampling to improve transparency and reduce selection bias, thereby strengthening the study’s validity. This approach was employed to mitigate selection bias and enhance statistical power, particularly given the relatively limited number of cases available for analysis.

The data extraction process from the medical records encompassed a wide range of variables, including socio-demographic, lifestyle, and clinical characteristics. Participants were categorized into four age groups (15–23, 24–32, 33–41, and 42–49 years) to capture reproductive life stages. The marital status variable was dichotomized into two categories: never married (including single and cohabiting in non-official unions) or ever married. Educational attainment was documented as secondary or tertiary education, reflecting the highest level completed. The lifestyle factors encompassed alcohol consumption and smoking habits, which were treated as binary variables (yes/no) based on patient self-report during clinical history-taking. The Body Mass Index (BMI) was classified according to the WHO criteria as normal, overweight, or obese.¹⁶ The reproductive history variables encompassed parity, gravidity, and abortion history, which were dichotomized as none, 1–2, or ≥3. The infertility characteristics were documented as type (primary or secondary) and duration, which was categorized into clinically relevant intervals (1–4, 5–9, and ≥10 years). The referral pathways were classified as confirmed for women who successfully underwent ART after referral to a private center and as lost for those who were referred but did not proceed with ART. This classification captures the health system bottleneck in access to advanced fertility care.

Statistical Analysis

Data were analyzed using SPSS version 28.0.0. Descriptive statistics, including frequencies and percentages for categorical variables and means with standard deviations for continuous variables, summarized the socio-demographic, lifestyle, and clinical characteristics of the study population.

Bivariate associations between each categorical explanatory variable and infertility type (primary vs secondary) were initially examined using chi-square tests. The dependent variable for all regression analyses was infertility type, with primary infertility specified as the reference category. This choice reflects our interest in identifying factors associated with secondary infertility.³

Candidate explanatory variables for the logistic regression model were selected based on a priori clinical relevance (age, education, BMI, alcohol use, duration of infertility, referral status) and any variable with p < 0.20 in bivariate analysis; this combined approach balances subject‑matter knowledge with data‑driven selection and is consistent with standard reporting recommendations.^2,5,17 The final multivariable model was constructed using the Enter method, simultaneously including all selected variables to adjust for potential confounding while avoiding the known limitations of stepwise selection, including overfitting and instability.¹⁸ Adjusted odds ratios (AORs) with 95% confidence intervals are reported; model fit was assessed using the Hosmer–Lemeshow test, and multicollinearity was assessed using variance inflation factors (VIFs). We interpreted marginally significant AORs (eg, the lower bound of the 95% CI close to 100) cautiously and reported exact p‑values.

Normative Component

Legal and Policy Review: Search Strategy and Data Sources

To complement the quantitative analysis, a systematic desk-based review of legal and policy instruments governing reproductive health and ART in the DRC was conducted, with the results contextualized within relevant international and regional frameworks. In light of the nascent state of legal epidemiology reporting standards and the recognized need for greater transparency in legal research methods for public health studies,^19,20 a structured approach was adopted to ensure the credibility and reproducibility of this normative component.

Databases and Sources Consulted

Legal and policy documents were identified through a multi-source search strategy encompassing:

Official legal databases: The DRC’s Journal Officiel de la République Démocratique du Congo (the official gazette for promulgation of laws and regulatory acts); Leganet.cd (the DRC’s primary online legal information portal); and le Recueil des lois et règlements de la RDC.

Academic databases: PubMed, Scopus, and Google Scholar were searched for peer-reviewed literature on reproductive health law, ART regulation, and infertility policy in Sub-Saharan Africa.

International legal repositories: The African Union’s legal instruments database; the World Health Organization’s institutional repository (IRIS); and the United Nations Treaty Collection.

Reports from WHO, UNFPA, the African Commission on Human and Peoples’ Rights, and the Solidarity for African Women’s Rights (SOAWR) coalition.

Search Terms and Strategy

Search terms were developed iteratively and adapted to each database’s syntax and controlled vocabulary. The following Boolean search strings were employed, combining terms related to jurisdiction, subject matter, and legal instrument type:

Geographic/jurisdictional terms: “Democratic Republic of the Congo” OR “Congo (Kinshasa)” OR “RDC” OR “DRC” OR “Congolese”

Subject terms: “reproductive health” OR “reproductive rights” OR “sexual and reproductive health” OR “assisted reproductive technology” OR “ART” OR “medically assisted procreation” OR “MAP” OR “procréation médicalement assistée” OR “PMA” OR “in vitro fertilization” OR “IVF” OR “infertility” OR “fertility care”

Legal instrument terms: “constitution” OR “law” OR “loi” OR “decree” OR “décret” OR “ordinance” OR “ordonnance” OR “regulation” OR “règlement” OR “policy” OR “politique” OR “protocol” OR “treaty” OR “charter”

International/regional framework terms: “Maputo Protocol” OR “African Charter on Human and Peoples’ Rights” OR “WHO guidelines” OR “international human rights” OR “ICESCR” OR “CEDAW”

Searches were conducted in both English and French to capture documents published in either of the DRC’s official languages.

Inclusion and Exclusion Criteria

Inclusion was required for primary DRC legal instruments, international treaties ratified by the DRC, or official policy documents addressing reproductive health. Emphasizing the document selection process enhances transparency and trust. These documents had to be published in English or French and explicitly relevant to infertility or ART. Excluded from the scope of the present study were draft legislation, unofficial commentaries, documents from other jurisdictions without DRC applicability, and instruments predating the 2006 Constitution unless still in force. The process of document selection and data extraction is illustrated in (Figure 1).

Figure 1.

Flow diagram summarizing document selection process.

Time Period Covered

The legal and policy instruments promulgated between January 2006 and December 2024 were included in the study, with the caveat that instruments from both international and regional bodies were included irrespective of their adoption date, provided that they had been ratified by the DRC.

Analytical Framework

The identified legal instruments were analyzed using a rights-based framework operationalized through the AAAQ (Availability, Accessibility, Acceptability, Quality) criteria, a recognized tool for evaluating health service delivery against human rights standards.²¹ This framework was supplemented by an ethical analysis that applied the principles of equity, autonomy, justice, and cultural sensitivity. The legal review and ethical analysis were conducted iteratively, with findings from each strand informing the other to generate integrated normative insights.

Integration of Quantitative and Normative Findings

The integration of empirical and normative components was central to the study design. Quantitative prevalence data were used to highlight demographic and clinical disparities, while the normative analysis provided a framework for interpreting these disparities in light of legal obligations and ethical principles. This methodological synthesis ensured that the study contributes both empirical evidence and normative insights to debates on reproductive justice, health system equity, and policy reform in the DRC.

Ethical Considerations

The present study received formal ethical approval from the Gynecological Clinic Elykia, following a comprehensive review of its research protocol and methodology, and was officially documented under the approval number CR/002/MD/2026, thereby ensuring compliance with institutional standards and regulatory requirements. Data were collected retrospectively and anonymously through document screening to assess eligible cases. No direct interviews or human testing were conducted; therefore, no individual informed consent was required, as the study relied exclusively on existing records without personal identifiers and complied with the Declaration of Helsinki.

Results

The prevalence of infertility among women seeking gynecologic care was estimated at 20%. The majority were aged 24–32 years (66.4%), followed by 33–41 years (28.1%). Most respondents were never married (69.9%) and had attained tertiary education (65.1%). Alcohol consumption was reported by 65.8%, while smoking was rare (0.7%). Obesity was prevalent (54.1%), with 28.1% overweight and 17.8% within the normal BMI range. Reproductive history revealed that 87.7% had never given birth, and 51.4% had never been pregnant. Abortion history showed that 52.1% had never experienced abortion, while 43.2% reported one to two abortions. The distribution of infertility types was almost even, with 51.4% having primary infertility and 48.6% experiencing secondary infertility. The duration of infertility was generally long, with 47.3% reporting 1–4 years and 45.9% reporting 5–9 years. A smaller percentage had infertility for over 10 years. Referral patterns showed that 69.2% were referred from primary-level facilities, while 30.8% came from tertiary centers (Table 1).

Table 1.

General Characteristics of the Study Population

Variables	Categories	n	%
Age	15–23	4	2.7
	24–32	97	66.4
	33–41	41	28.1
	42–49	4	2.7
Marital status	Never	102	69.9
	Ever	44	30.1
Education	Primary	0	NA
	Secondary	51	34.9
	Tertiary	95	65.1
Alcohol	No	50	34.2
	Yes	96	65.8
Smoking	No	145	99.3
	Yes	1	0.7
BMI	Normal	26	17.8
	Overweight	41	28.1
	Obesity	79	54.1
Parity	Never	128	87.7
	1–2	16	11.0
	3–4	2	1.4
Gestity	Never	75	51.4
	1–2	55	37.7
	3–4	14	9.6
	5 and over	2	1.4
Abortion	Never	76	52.1
	1–2	63	43.2
	3–4	7	4.8
Type of Infertility	Primary	75	51.4
	Secondary	71	48.6
Time of Infertility (in years)	1–4	69	47.3
	5–9	67	45.9
	10–13	6	4.1
	14–18	4	2.7
Referred from	Confirmed	101	69.2
	Lost	45	30.8

Abbreviation: NA, Not applicable.

Bivariate Associations by Infertility Type

Table 2 presents the distribution of participant characteristics by infertility type. Primary infertility was more prevalent among younger women (24–32 years: 55.7%), whereas secondary infertility was more common in the older age group (33–41 years: 58.5%). With respect to marital status, categorized as never married (including single and cohabiting in unofficial unions) or ever married (including currently married, widowed, divorced, or separated), primary infertility was more frequent among never-married women (55.9%), while secondary infertility predominated among ever-married women (59.1%). This pattern is consistent with the definitional requirement that secondary infertility presupposes a prior pregnancy, which in the Congolese sociocultural context occurs predominantly within marital unions. Women with tertiary education had a higher proportion of secondary infertility (52.6%), whereas primary infertility was more frequent among those with secondary education (58.8%). Among alcohol consumers, secondary infertility was slightly more common (52.1%), whereas primary infertility predominated among non-drinkers (58.0%). Secondary infertility was marginally more prevalent among obese women (50.6%), whereas primary infertility was more frequent among women with normal BMI (57.7%).

Table 2.

Chi-Square Test of Respondent Characteristics by Infertility Types

Variables	Type of Infertility
	Primary	Secondary
Age
15–23	2 (50)	2 (50)
24–32	54 (55.7)	43 (44.3)
33–41	17 (41.5)	24 (58.5)
42–49	2 (50)	2 (50)
Marital status
Never	57 (55.9)	45 (44.1)
Ever	18 (40.9)	26 (59.1)
Education
Primary	NA
Secondary	30 (58.8)	21 (41.2)
Tertiary	45 (47.4)	50 (52.6)
Alcohol
No	29 (58)	21 (42)
Yes	46 (47.9)	50 (52.1)
Smoking
No	75 (51.7)	70 (48.3)
Yes	0	1 (100)
BMI
Normal	15 (57.7)	11 (42.3)
Overweight	21 (51.2)	20 (48.8)
Obesity	39 (49.4)	40 (50.6)
Parity (<0.001)
Never	75 (58.6)	53 (41.4)
1–2	0	16 (100)
3–4	0	2 (100)
Gestity (<0.001)
Never	75 (100)	0
1–2	0	55 (100)
3–4	0	14 (100)
5 and over	0	2 (100)
Abortion
Never	75 (98.7)	1 (1.3)
1–2	0	63 (100)
3–4	0	7 (100)
Time of Infertility (in years)
1–4	31 (44.9)	38 (55.1)
5–9	39 (58.2)	28 (41.8)
10–13	3 (50)	3 (50)
14–18	2 (50)	2 (50)
Referred for ART
Confirmed	59 (58.4)	42 (41.6)
Lost	16 (35.6)	29 (62.4)

Note: Chi-square test significant at 0.05,

Abbreviation: NA, Not applicable.

As expected by definition, parity, gravidity, and abortion history showed strong structural associations with infertility type: primary infertility was observed exclusively among women with no prior pregnancies or abortions. In contrast, secondary infertility was universal among women with a history of prior pregnancy or abortion.

Regarding infertility duration, secondary infertility was more common among women with shorter durations (1–4 years: 55.1%), whereas primary infertility was more frequent among those with longer durations (5–9 years: 58.2%). Referral outcomes revealed that women with primary infertility were more likely to be confirmed for ART following referral (58.4%). In contrast, those with secondary infertility were disproportionately represented in the lost-to-follow-up group (62.4%) (Table 2).

Multivariable Logistic Regression Analysis

As shown in Table 3, three variables were independently associated with secondary infertility. Hosmer-Lemeshow goodness-of-fit test indicated acceptable model calibration (χ² = 6.23, df = 8, p = 0.62). Women with tertiary education had significantly higher odds of secondary infertility compared with those whose education did not extend beyond the secondary level (AOR = 2.58, 95% CI: 1.07–6.23). Alcohol consumption was also associated with increased odds of secondary infertility relative to non-consumption (AOR = 2.45, 95% CI: 1.07–5.10). Referral status emerged as the strongest correlate: women lost to follow-up had more than three times the odds of secondary infertility compared with those confirmed for ART (AOR = 3.20, 95% CI: 1.24–8.26). While these associations reached statistical significance (p < 0.05), the relatively wide confidence intervals, particularly for education and alcohol use, suggest modest precision and warrant cautious interpretation. Age, marital status, BMI, and duration of infertility were not significantly associated with infertility type in the adjusted model (Table 3).

Table 3.

Crude and Adjusted Odds Ratios for Factors Associated with Infertility from Binary Logistic Regression

Predictors	Type of Infertility
	COR	CI	AOR	CI
Age
15–23	1
24–32	0.78	(0.11–5.89)	0.51	(0.51–5.01)
33–41	1.41	(0.18–11.03)	1.18	(0.10–13.86)
42–49	1	(0.06–15.99)	0.45	(0.21–9.57)
Marital status
Never	1
Ever	1.83	(0.89–3.75)	1.01	(0.42–2.47)
Education
Secondary	1
Tertiary	1.59	(0.79–3.15)	2.58	(1.07–6.23)a
Alcohol
No	1
Yes	1.5	(0.75–2.99)	2.45	(1.07–51)a
BMI
Normal	1
Overweight	1.3	(0.48–3.49)	1.46	(0.47–4.48)
Obesity	1.4	(0.57–3.42)	1.46	(0.49–4.28)
Time of Infertility (in years)
1–4	1
5–9	0.58	(0.29–1.15)	0.53	(0.24–1.19)
10–13	0.81	(0.15–4.33)	0.41	(0.58–2.85)
14–18	0.81	(0.11–6.12)	0.39	(0.38–4.07)
Referred to ART
Confirmed	1
Lost	2.55	(1.23–5.27)a	3.2	(1.24–8.26)a

Note: 1: Reference group; ^aSignificant at p-value < 0.05–0.01.

Abbreviations: COR, Crude Odds Ratio; AOR, Adjusted Odds Ratio.

Discussion

This study offers one of the first empirical examinations of infertility and access to ART in the DRC, combining quantitative patient data with normative legal and ethical analysis. Our findings highlight a significant gap between the progressive legal framework for reproductive health in the DRC and the everyday experiences of women seeking fertility care. This discussion combines empirical and normative insights to explore the implications for reproductive justice, gender equity, and health system reform in the DRC and similar low-resource settings.

Integration of Empirical Findings with Normative Analysis

The DRC presents a compelling case study in the global struggle for reproductive health equity. While the nation has constructed a progressive legal edifice recognizing reproductive rights, including access to ART, this normative foundation contrasts starkly with implementation realities. The Congolese Constitution (Articles 14 and 53) mandates the elimination of discrimination against women and guarantees the right to health.²² Law n° 18/035 explicitly recognizes ART as part of available reproductive health services.¹⁰ This legislative framework aligns the DRC with international standards, including the Maputo Protocol’s requirement that states provide access to reproductive health services⁷ and the WHO’s assertion that fertility care is a crucial aspect of reproductive health.¹⁴

However, our empirical findings expose the significant gap between legal recognition and practical realization. Among 146 women presenting for infertility consultation at a specialized center in Kinshasa, only 69.2% were confirmed for ART referral, while 30.8% were lost to follow-up. Critically, women with secondary infertility were significantly more likely to be lost to follow-up (AOR = 3.2, 95% CI: 1.24–8.26), indicating systematic disadvantages in accessing advanced fertility care. This finding acquires normative significance when viewed through the AAAQ (Availability, Accessibility, Acceptability, Quality) framework, a rights-based tool for evaluating service delivery.²³

Availability is virtually non-existent in the public sector. With no state-run ART centers, services are confined to private facilities in Kinshasa and Lubumbashi, creating a “reproductive health desert” for the majority of the population. Recognizing this gap can motivate stakeholders to advocate for change, emphasizing their vital role in improving access and health equity. This absence renders the legal recognition of the ART functionally meaningless for most citizens. As legal scholars observe, constitutional provisions establishing health rights shift from aspiration to enforceable state responsibility only when accompanied by implementation mechanisms.²⁴ The DRC’s legislative inertia transforms what could be an instrument for equity into a mechanism that implicitly endorses private, market-driven access.²⁵

Accessibility failures emerge from our finding that individuals with tertiary education are twice as likely to experience secondary infertility (AOR = 2.58, 95% CI: 1.07–6.23). This relationship may reflect delayed childbearing due to career development²⁶ and longer birth intervals among educated women.²⁷ It also highlights the critical role policymakers and health professionals play in reducing inequality in infertility diagnosis. Those with lower educational attainment might never reach specialized facilities, remaining unrecognized in clinical data and policy planning. The WHO’s 2025 guideline explicitly advocates reducing “catastrophic out-of-pocket expenditures” associated with ART, emphasizing the importance of policy actions that protect financial risk within universal health coverage.²⁸

Acceptability requires that health services be respectful of medical ethics, culturally appropriate, and responsive to the needs of individuals and communities. In the context of infertility care, acceptability encompasses not only the provision of technically competent services but also the integration of fertility care with broader reproductive health services, including prevention, education, and psychosocial support.²⁹ Our findings highlight significant challenges in this dimension. The high prevalence of obesity (54.1%) in our sample is consistent with growing evidence associated with elevated BMI to ovulatory dysfunction, reduced conception rates, and poorer ART outcomes, consistent with previous studies,^17,30,31 Similarly, the high rate of alcohol consumption (65.8%), which was independently associated with secondary infertility (AOR = 2.45, 95% CI: 1.07–5.10), aligns with research demonstrating alcohol’s adverse effects on ovarian reserve, hormonal regulation, and implantation.^32,33 However, rather than viewing these as solely individual-level behavioral factors, the acceptability lens directs attention to the health system’s failure to provide integrated, preventive reproductive health services that address these modifiable risk factors before women present with infertility. A system that responds only to established infertility, rather than offering comprehensive preconception care, weight management support, and substance use counseling, may fail to meet the standard of acceptability by neglecting the full spectrum of women’s reproductive health needs.³⁴

Quality failures manifest in the absence of comprehensive regulatory standards governing ART practice. The World Medical Association’s revised statement on ART underscores the ethical imperatives of reproductive autonomy, non-discrimination, and equitable access.³⁵ However, the DRC lacks specific guidelines for licensing, clinical procedures, gamete donation, embryo management, or surrogacy, practices that occur through private legal contracts without formal recognition.¹⁰ This regulatory vacuum puts patients at risk of exploitation and harm³⁶ (Figure 2).

Figure 2.

The AAAQ framework used to assess ART service delivery in the DRC context. Source Adapted from General Comment No. 14 of the UN Committee on Economic, Social and Cultural Rights (CESCR) and WHO guidance on the AAAQ framework.

Reproductive Stratification and Ethical Implications

The fundamental ethical dilemma concerns the tension between formal acknowledgment and genuine equality. The DRC exhibits a failure to respond equitably to infertility, thereby perpetuating what Colen³⁷ terms “reproductive stratification”. This term refers to the organized sorting of reproductive capabilities along societal hierarchies. In the Congolese context, this phenomenon manifests across geographical divides (urban versus rural), socioeconomic factors (ability to afford private care), and reproductive backgrounds (primary versus secondary infertility). The dearth of public ART infrastructure has been shown to privilege the affluent, thereby subverting constitutional guarantees and amounting to discrimination based on socioeconomic status.

This stratification raises significant questions about distributive justice. Infertility constitutes a dual challenge, simultaneously impacting individuals and society at large. This phenomenon, characterized by the inability to conceive, is not merely a personal medical concern but also a public health issue, bearing significant social and psychological ramifications.³⁸ In circumstances where ART access is contingent upon private wealth rather than medical necessity, reproductive rights may remain aspirational, failing to translate into tangible actions. The principle of progressive realization, as articulated in the International Covenant on Economic, Social, and Cultural Rights,³⁹ requires states to take intentional actions toward comprehensive implementation of health rights. Despite the pressing resource constraints, the Covenant stipulates that states must prioritize fundamental obligations by leveraging the maximum available resources.²⁴ The existence of private ART clinics in Kinshasa and Lubumbashi suggests technical capacity. However, the primary challenges appear to be a lack of political will and a failure to allocate resources judiciously.

Comparison with Global and Regional Evidence

The present findings reinforce the mounting body of evidence highlighting significant disparities in access to ART. Dyer et al,³ report that although approximately 25 million ART cycles are performed worldwide each year, the vast majority occur in high-income countries. The DRC serves as a prime example of this imbalance, where infertility is pervasive yet access to ART remains virtually non-existent.

The use of regional comparisons illustrates the broad spectrum of challenges encountered. In South Africa, the public sector has established services to provide ART, yet access remains limited and uneven.³ Kenya has recently developed a regulatory framework for private ART services; however, public provision remains limited.⁴ The DRC exhibits a notable deficit in both the availability of public ART services and the implementation of comprehensive regulatory frameworks. However, the DRC’s legal framework is comparatively progressive. The formal recognition of ART in national law constitutes a significant milestone that many African nations have yet to achieve. This acknowledgment signifies a political determination and alignment with international norms. Nevertheless, the absence of implementation mechanisms renders it largely symbolic, lacking the potential for substantive transformation.

Implications for Reproductive Justice, Gender Equity, and Health System Reform

Reproductive justice, a comprehensive framework encompassing the rights to have children, not have children, and raise children in safe communities,⁴⁰ is imperative for a comprehensive understanding of our findings. The DRC’s failure to ensure universal access to antiretroviral therapy (ART) signifies not merely a deficiency in service delivery, but rather, a significant impediment to women’s full realization of their reproductive rights.

The implications for gender equity are particularly significant. In cultures where women’s social status is closely tied to motherhood, infertility emerges as a pronounced vulnerability.² Our observation that 69.9% of women seeking infertility treatment have never been married underscores the urgency among unmarried women to establish fertility, likely in anticipation of future marriage or in response to societal pressures to demonstrate reproductive potential. Women are subject to a disproportionate amount of societal blame for their infertility, irrespective of the underlying causes, and they are concurrently confronted with elevated risks of relationship dissolution and social exclusion.³ The health system’s failure to address infertility equitably serves to exacerbate existing gender disparities.

Health system reform must extend beyond ART. The high prevalence of secondary infertility indicates failures in primary prevention, including inadequate management of sexually transmitted infections, limited access to safe delivery care, and restricted abortion services.²⁵ A comprehensive approach would entail integrating infertility prevention and treatment into universal health coverage frameworks, as recommended by the WHO’s 2025 guideline.²⁸

Policy Recommendations for the Democratic Republic of Congo

Based on the integration of empirical and normative findings, the following key policy actions are proposed:

Establishing a national regulatory framework for ART is imperative. Law No. 18/035 establishes general provisions; however, it lacks specific regulations that govern ART practice. A comprehensive framework must encompass licensing and oversight of ART facilities, clinical and laboratory standards, guidelines for gamete donation, embryo management, and surrogacy (if permitted), and mechanisms to protect patient rights and prevent exploitation. The ethical principles articulated in the World Medical Association’s 2022 ART statement³⁵ and comparative regulations³⁶ can serve as a framework for this process.

Secondly, integrating fertility care into the framework of Universal Health Coverage (UHC) is imperative. The widespread use of private services has the potential to undermine equitable principles and exacerbate socioeconomic disparities. A phased implementation plan should commence with the provision of preventive services and fundamental diagnostics at primary and secondary levels. This should then progress to facilitating subsidized ART access for underserved populations. Ultimately, the plan should culminate in the establishment of public ART centers within tertiary hospitals.

Thirdly, efforts must be made to enhance the efficacy of primary prevention of infertility. To address this issue, there is a need to prioritize the following: comprehensive sex education, increased access to contraception, the availability of safe abortion services, the effective management of sexually transmitted infections, and the provision of quality maternity care to mitigate postpartum complications.

Fourthly, developing national clinical guidelines and training programs is necessary to build capacity for infertility care across all health system levels.

The fifth imperative is to establish surveillance and research capacities. The objective of this initiative is to generate reliable national data on the prevalence of infertility, its causes, and treatment outcomes. The generation of this data will enable the development of evidence-based policy.

It is imperative that international standards, including the Maputo Protocol, be fully implemented through national legislation, budget allocations, and monitoring mechanisms. These measures must be supported by civil society and international cooperation.

Conclusion

This study highlights a profound disconnect between the constitutional recognition of reproductive rights and the practical realities of infertility care in the DRC. Among the women followed at a specialized clinic in Kinshasa, we observed nearly equal proportions of primary and secondary infertility. Loss to follow-up after referral to a specialist emerged as the most significant indicator of systemic failure, with women who have secondary infertility being disproportionately affected. A normative analysis confirms that, although national legislation formally recognizes ART, the lack of public infrastructure dedicated to ART renders this right inaccessible in practice, thereby perpetuating reproductive stratification based on socioeconomic status.

The experience of the DRC illustrates a broader challenge facing low- and middle-income countries: translating the legal recognition of health rights into equitable and accessible services. Infertility care is not merely a medical concern, but a lens through which to examine social justice, gender equality, and the realization of health as a human right. For millions of Congolese women, this remains a matter of fundamental dignity and the right to start a family, a right that, for now, remains unrealized.

Disclosure

The authors report no conflicts of interest in this work.