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. 2023 Feb 17;9(3):e13838. doi: 10.1016/j.heliyon.2023.e13838

A supportive randomized clinical trial on Iranian infertile women with the history of infertility treatments dropout following unsuccessful ART cycle/s: A study protocol

Maryam Ghorbani a, Fatemeh Sadat Hoseini b, Masud yunesian c, Shahrbanoo Salehin d, Seyedeh Solmaz Talebi e, Afsaneh Keramat f,∗
PMCID: PMC9984792  PMID: 36879964

Abstract

Introduction

Due to high dropout rate of infertility treatments and lack of any intervention for motivating infertile couples to continue treatments, the present study will be conducted with the aim of designing, implementing and determining the effectiveness of the proposed intervention in order to continue infertility treatments.

Methods

& Analysis: We will conduct this study in two stages; a review of literature and past studies will be done to identify interventions that have been performed for infertile couples, and then an appropriate intervention with the aim of continuing infertility treatments for infertile women will be designed. After that a Delphi study will be designed in accordance with collected information of previous stages and will be approved by experts. In the second stage we will implement designed intervention of a randomized clinical trial on two groups of infertile women (control and intervention) with the history of infertility treatment dropout following unsuccessful cycle. We will use descriptive statistic in first and second stage. In second stage Chi square test and independent samples T test will be used to compare variables between groups and variables in study questionnaires before and after the intervention between two groups of study.

Discussion

The present study will be the first study to be performed as a clinical trial on infertile women who have discontinued the treatments, with the aim of continuing treatments. Thereupon, it seems that the results of this study will be the basis for studies around the world to prevent premature cessation of infertility treatments.

Keywords: Infertility, Dropout, Intervention, Randomized clinical trial

Highlights

  • •

    This Study will be the first interventional study that encourages infertile couples with history of failure in infertility treatments to continue treatments.

  • •

    The study design is unique and type of interventions will be determined based on contributor's needs and consensus of experts.

  • •

    The results will contribute to the development of an evidence-based framework for supporting infertile couples to continue treatments.

  • •

    Recruitment is limited to infertile couples who had medical file in infertility centers.

1. Introduction

It is well-established that parenthood is a protective factor against marital separation or divorce [1,2] and it is obvious about infertility to be a risk factor for the stability of marital life [[3], [4], [5]]. The majority of people involved in infertility issue, live in third world countries [3]. Since in these countries, a woman's economic and social values are directly related to her ability to conceive and give birth to a child, the psychological consequences of infertility such as family breakup or divorce and remarriage are also common [[6], [7], [8]]. Following the increase in infertility, the number of patients seeking ART (Assisted Reproductive Technology) treatments in the late third and early fourth decade of life is also increasing [9].

However, the success rate of these techniques is about 25% per cycle until the age of 35, and after this age is greatly reduced. On the other hand, this success rate means that the failure rate of these methods is about 75%. This high rate of failure could be distressing for people who bear the heavy financial and psychological costs of these treatments [10] and therefore many couples give up these treatments before the results are achieved [[11], [12], [13], [14]].

Dropout of infertility treatments is a phenomenon that research about it started in 1980 and the motivation for this research, was to find the causes of dropout in infertile couples [15]. In these studies, various causes and factors have been identified in the cessation of infertility treatments, such as psychological burden, personal and marital problems, poor diagnosis, demographic and social factors and parity, financial issues and high costs, interpersonal and marital issues, Feelings of futility of treatment, religious beliefs, cultural taboos, fear of infection, fear of failure of methods, fear of side effects and shame of using assisted reproductive techniques, were the causes and factors which influence the abandonment of infertility treatments [11,12,[15], [16], [17], [18]].

Hence, despite various studies to identify the causes and factors involved in dropout of infertility treatments, no intervention has been made to prevent premature termination of infertility treatments and interventions are needed to be considered in order to continue the treatment. Therefore, the present study will be conducted with the aim of designing, implementing and determining the effectiveness of the proposed intervention in order to continue infertility treatments.

1.1. Main objective

Presenting and evaluating a designed intervention for motivating infertile women to continue infertility treatments.

1.2. Specific objectives

Objectives of the first stage (designing intervention):

  • •

    Designing a suitable and feasible intervention

Objectives of the second stage (implementing the supportive intervention):

  • •

    Evaluating the effectiveness of the supportive intervention on intention to continue treatment in infertile women

  • •

    Evaluating the effectiveness of the supportive intervention on infertility stress and stress coping styles in infertile women

  • •

    Evaluating the effectiveness of the supportive intervention on mental health in infertile women

  • •

    Evaluating the effectiveness of the supportive intervention on communication skills in infertile women infertile couples

2. Materials & methods

2.1. This study will be done in two stages

In the first stage, to design an appropriate intervention with the aim of continuing infertility treatments in infertile women, a review of literature and past studies will be done to identify educational and supportive interventions that have been performed on infertile women. Then a Delphi study will be designed with the result of collected information, until the proposed and designed intervention is approved by experts. At this stage of the research, the classic Delphi method will be used by purpose-based sampling and the opinions sufficient numbers of experts in the field of infertility will be used. The participating experts will be university professors, researchers, specialists and employees in the field of infertility who have sufficient knowledge in the field of the research topic and could influence the results of the research.

The second stage is the implementation of designed intervention of a randomized clinical trial (RCT). Fig. 1 shows the method flow chart of the study.

Fig. 1.

Fig. 1

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Method flow chart of the study.

2.2. Trial design and oversight

We will conduct a randomized clinical trial to evaluate effectiveness of a planned supportive intervention on infertile women. Participants will complete written informed consent. Oversight of trial included a trial management group and data monitoring committees of Shahroud University of Medical Sciences. Eligible patients will be entered by block randomization method in intervention and control groups, the results of each group will be reported separately and compared.

2.3. Patient involvement

Patients will be involved in design and conduct of this research. During the feasibility stage, priority of research question, choice of outcome measures and methods of recruitment will be informed by discussions with patients through an introducing session. Members of the research team and university experts identified this research as being a priority for infertile women seeking infertility treatments. Once the trial has been published, participants will be informed of the results through a WhatsApp groups.

2.4. Research population

The statistical populations are infertile 18–42-year-old women of reproductive age who visit the infertility treatment centers to receive the IVF/ICSI (Intra Cytoplasmic Sperm Injection), and FET (Frozen Embryo Transfer) services in infertility centers of Qom, Iran.

2.5. Research sample

The research samples are 130 infertile women (by considering 10% as attrition of samples) (65 women in control group and 65 women in intervention group). We measured the sample size based on the following equation:

n=(Z1−∝13+Z1−β)2[P1(1−P1)+P3(1−P3)](P1−P3)2

where, α = 0.05 → Z1-α/.2 = 1.96: is the Percentile of a normal distribution of the Type I error (5%).

P1 = 0.4: current rate of continuing treatment.

P2 = 0.65: expected rate of treatment continuation.

Β = 0.2→ Z1- Β = 0.84.

2.6. Characteristics of research samples

  • •

    Infertile women at the childbearing age of 18–42

  • •

    Having at least an unsuccessful history of IVF/ICSI and FET cycle (failure to seek treatment after at least a 6-month follow-up period following last unsuccessful treatment is considered as dropout of treatment according to a study conducted by Moini et al.) [14].

  • •

    Having a medical record at the infertility centers

  • •

    Voluntary participation and written informed consent

  • •

    Having Iranian nationality (couple)

  • •

    No history of narcotic and psychotropic drugs addiction

  • •

    Fluency in Persian language

2.7. Exclusion criteria

Reluctance to finish the study and become pregnant.

2.8. Sampling methods

2.8.1. First stage

At this stage, with the goal of designing an appropriate intervention, a review of literature and past studies will be done to identify the educational and supportive interventions that have been performed on infertile couples so far. Moreover, the results of reviewing texts and previous research conducted by us and our colleagues will also be used. This study was a quantitative-qualitative study on infertile couples in which the incidence of treatment dropout among infertile couples referred to infertility treatment centers in Qom was determined in a retrospective cohort study, and then qualitative interviews were conducted among couples receiving infertility treatment to identify factors influencing infertility treatment. However, the results of this study have not yet been published, one of the reasons given by infertile women for dropout of infertility treatments was the stress caused by treatments and infertility and the use of wrong strategies to cope with stress. The way people around them deal with infertile couples and the inability to interact properly with them were other reasons for dropout. These cases were examples of the most important reasons raised in this study by infertile couples for stopping treatment.

After collecting information, a Delphi study will be designed. Due to the fact that there are basic information about this research, a semi-structured or structured questionnaire can be prepared [19]. This questionnaire contains suggested interventions for continuing infertility treatments for infertile women with a history of treatment failure (IVF, ICSI, FET) and will be designed on a Likert scale, and at the end of each item, participants will be given the opportunity to submit comments, suggestions and reasons for rejection or acceptance. Then the relevant experts will be selected based on the purposive sampling [20,21] and questionnaires will be provided to them and their answers will be gathered and organized in the first round [20,22]. After that qualitative analysis will be performed for the results of this round. These results will provide a basis for constructing questionnaires in next rounds.

In the second round, the questionnaire prepared in the first round is given back to the same participants and they are asked to review the items collected by the researchers based on the information provided in the first round and classify them using the Likert scale [[23], [24], [25]].

Since in Delphi studies, the number of rounds can vary from 2 to 10 rounds [26], in the present study, the number of rounds is determined according to the purpose of the study, the knowledge of the participants and the time to reaching consensus, and then based on the results of the Delphi panel of experts, a supportive educational intervention of a randomized clinical trial will be designed.

2.8.2. Second stage

At this stage, the designed intervention will perform. Therefore, a randomized clinical trial will be performed by convenience sampling method. Random assignment of research samples to intervention and control groups will be done using block randomization method and using quadruple blocks, thus the researcher will not have the chance to change the assignment status of individuals or their predictions, so 65 women will be selected for intervention and 65 women for control group. Participation in the control group and 65 people will be selected to participate in the intervention group. Randomization process will be done by an external researcher to reduce the bias to minimal score. Blinding of participants and training providers to intervention or control group allocation is not possible in this study owing to the type of intervention will be educational talents.

Samples are selected from clients who have referred to the infertility treatment centers in Qom, Iran in a two-year period (from the April of 2018 to the end of March 2020) and meet the inclusion criteria, and they will be contacted by phone. Due to the prevalence of Covid 19 disease and the risk of disease transmission, an online meeting will be held before the start of the study for those who have expressed their desire to participate in the study to provide information about the goals and methods of research to participants.

The informed consent of the research participant is also sent to the participants and is taken from them. Then the intervention begins. The intervention will be done in a group format (with groups of 15–20 people). Prior to the intervention, participants in both groups will complete demographic and midwifery questionnaires.

Also, due to the effect of disorders such as depression and generalized anxiety disorder on the research results and the possibility of bias in the results, participants are screened with the GHQ-28 (General Health Questionnaire) before entering the study and being in the intervention and control groups [27] in case of diagnosis of mental health disorders, to treat and prevent bias in the results, to be referred to psychiatrists and prevent them from entering the study. This questionnaire has 4 scales of general health, anxiety and sleep disorder, social dysfunction and depression. Since a score of 61–84 in this questionnaire means that a person's mental health has been damaged in many aspects and one should think about improving his living conditions and mental health [28]. In the current study, the patients who received a score of 61 or higher will not include in the study and will be referred to a qualified psychologist or psychiatrist to receive psychiatric services or psychological counseling. For such cases we will adjust this variable to compare different groups.

Also, all participants in both groups will complete the Fertility Problem Inventory (FPI) and Queendom communication skills inventory (CSTR) questionnaires before and two weeks after the end of the intervention for comparing variables [28,29].

In order to measure the intention to continue treatment and the stages of behavior change (meaning behavior change in order to continue infertility treatments), a questionnaire will be prepared based on the structures of the trans-theoretical model [30,31] whose content validity in two quantitative ways and quality will be evaluated by relevant experts. To confirm the validity, a quantitative method will be used and the questionnaire will be provided to 10 patients referred to the infertility centers and the Impact Score of each item will be determined according to the following formula: Impact Score: Frequency × Importance.

Intervention will be in 4 sessions of 1 h online per week (using Skype software) to present the main issues of the intervention and 6 sessions (twice a week) to provide easier content by forming a group in cyberspace (using WhatsApp software). The content of the training sessions will be determined according to the results of previous studies. The control group will not receive any intervention from the research team. To promote participants for completing the research, a gift will be determined according to consensus of research team.

3. Data analysis method

3.1. In delphi stage

Descriptive statistic including mean and standard deviation will be applied for consensus. Incidentally, consensus on research items will be considered in this way:

A consensus will be reached if at least 70% of the participants agree/agree the most or disagree/disagree the most with each item in the last round. This level of consensus has been confirmed in several previous studies [21,32,33].

3.2. In intervention stage

3.2.1. Primary outcome

The main outcome measure is intention to continue treatment which will be measured before and 2 weeks after the end of intervention by a questionnaire based on the structures of the trans-theoretical model.

3.2.2. Secondary outcomes

General health, fertility stress and communication skills are the secondary outcomes which will be assessed by questionnaires before and two weeks after the end of intervention. More secondary variables will be recognized after end of review and Delphi panel.

Descriptive statistics including frequency, mean and standard deviation tables will be used to express the characteristics of the research units. For example:

  • •

    Female and male's age, duration of marriage, duration of infertility, age of marriage, age of menarche will be described by mean and standard deviation. We will use independent samples to compare these variables between groups.

  • •

    Place of residency, infertility cause, number of pregnancies, abortions and live children will be described by frequency and proportion. We will use Chi square test to compare these variables between two groups of study. If the independent variables have a statistically significant difference between the two groups, we will use more advanced statistical tests such as regression or Generalized Estimating Equations (GEE) method to investigate the effect of the independent variables that have difference in the two groups on the outcome variables.

  • •

    We will use paired sample T test to compare mean scores of study questionnaires for outcomes including general health, fertility stress and communication skills and other outcomes that are important for assessing intervention before and after the intervention between two groups of study.

3.3. Participants’ characteristics

Women who have been diagnosed infertile and at least a history of unsuccessful IVF/ICSI or FET treatment will be considered as Research participants.

3.4. Research environment

Due to the prevalence of Covid 19 disease, it is not possible to hold a face-to-face class. Therefore, the classes will be held online in the homes of the research participants. But the participants will be selected from the clients Infertility Treatment Centers of Qom University.

4. Discussion

Based on studies, dropout of infertility treatments is a common concern and has a different range in different parts of the world [13,34,35]. In Iran, it was reported 28.3% [36] in one study and 56.5% in another study [14]. In view of the fact that infertility is a global phenomenon and having children is of great importance in many cultures, especially Iranian culture, at the global level, special attention should be paid to the issue of discontinuation of the treatment.

Nevertheless, a brief look at the research done in the world, shows that no intervention has been done so far with the aim of continuing infertility treatments and the existing studies only know the extent of treatment dropout; effective causes and factors and providing educational-psychological interventions in infertile couples [37,38].

For instance, Chan et al. conducted a randomized clinical trial before starting treatment on 227 infertile women who were to undergo their first IVF treatment cycle. The intervention was in the form of providing information and training in relaxation skills through the formation of groups of 7–10 people, and finally the level of anxiety and pregnancy in the two groups of intervention and the control group were measured and compared [39].

As another example, a randomized clinical trial was done on 140 infertile couples diagnosed with depression. The intervention was a form of cognitive-behavioral therapy and supportive therapy which took 6 months, but again the psychological results and marital satisfaction were compared between the intervention and control groups and, just like other studies, the issue of discontinuation of treatment was ignored (41).

This research will encounter with some limitations, for example the sensitivity of the subject and the fear of the stigma of infertility is the first and most fundamental limitation of this research. Considering the dominant culture in the society and the importance of having children in Iranian culture, a high percentage of infertile people tend to hide the problem in order to escape the stigma of infertility and being labeled, and therefore they may not want to communicate and refuse to provide information. Another limitation is the participation of men and the provision of training for them. Since infertility is a problem related to the couple and both of them are involved in this problem and the problems associated with it, it is quite clear that interventions should be provided for both infertile couples in order to be more effective and better able to deal with It judged. According to the past studies conducted by us, the non-participation of men in the current study is one of the problems that will exist in all stages of the implementation of this research. Because according to our experiences and cultural issues, men in the society fear the disclosure of information and the stigma of infertility, so they will not cooperate to participate in the research.

So, it is essential to intervene in infertile couples who have abandoned infertility treatments and evaluate their effectiveness. According to our knowledge, the present study will be the first study to be performed as a clinical trial on infertile women who have discontinued the treatment, in order to compare the extent of intention to continue the treatment and psychological conditions between them and control group; such as depression, anxiety, stress, etc. Thereupon, it seems that the results of this study will be the basis for intervention studies around the world to prevent premature cessation of infertility treatments.

Ethics and dissemination

This study is a part of PhD thesis and was supported by Grant No 97198 from Shahroud University of Medical Sciences and has been approved by the Ethics Committee of Shahroud University of Medical Sciences (Approval ID:IR.SHMU. REC.1397.235, Approval date: 2019/3/11). The researchers will inform all participants about the aim of the study and written informed consent from each participant will be taken. This study has registration of in the Iranian Center for Registration of Clinical Trials (IRCT20210516051315N1).

Personal information of all participants will be confidential in all stages of conducting study and after its end. Findings of the study will be disseminated in peer-reviewed journals. We will make a lay summary of results publicly on Shahroud University of Medical Sciences. Our results will contribute to the development of an evidence-based framework for continuing infertility treatments.

Author contribution statement

Maryam Ghorbani: Conceived and designed the experiments; Performed the experiments; Analyzed and interpreted the data; Contributed reagents, materials, analysis tools or data; Wrote the paper. Fatemeh Sadat Hoseini; Shahrbanoo Salehin: Conceived and designed the experiments; Contributed reagents, materials, analysis tools or data. Masud Yunesian; Seyedeh Solmaz Talebi: Conceived and designed the experiments; Analyzed and interpreted the data; Contributed reagents, materials, analysis tools or data. Afsaneh Keramat: Conceived and designed the experiments; Contributed reagents, materials, analysis tools or data; Wrote the paper.

Funding statement

This study was supported by Shahroud University of Medical Sciences [Grant No 97198].

Data availability statement

No data was used for the research described in the article.

Additional information

The clinical trial described in this paper was registered at The Iranian Registry of Clinical Trials under the registration number IRCT20210516051315N1.

Declaration of competing interest

The authors declare no competing interests.

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