Explaining the Process of Coping With Successful Assisted Reproductive Treatment Among Infertile Couples and Designing a Supportive Care Program: A Grounded Theory Study Protocol

Abstract

Introduction

Infertility is a global health concern that significantly impacts the physical, emotional, and social well-being of affected couples. While ART enhances the likelihood of conception, the post-treatment phase introduces psychological and social challenges that may influence both Parents and neonatal outcomes. Despite the importance of this transitional period, the coping mechanisms of infertile couples following successful ART remain insufficiently explored. This study aims to develop a comprehensive understanding of the coping process in infertile couples after successful ART treatment and to design a tailored supportive care program that addresses their specific needs. Our study objectives are: 1. To explore and explain the coping process of infertile couples following pregnancy achieved through ART. 2. To develop and validate a supportive care program based on the needs identified during the qualitative phase.

Methods and Analysis

In the first phase, a qualitative study will be conducted using Corbin and Strauss’s (2015) grounded theory methodology. Participants will include infertile couples with successful ART outcomes, key stakeholders, healthcare providers, and other relevant informants. Data will be collected through in-depth semi-structured interviews, field notes, and memos, using purposive and theoretical sampling until data saturation is achieved. Data analysis will proceed through five stages: concept generation, development of dimensions and properties, contextual analysis, integration of process, and category integration to identify the core category. In the second phase, findings from the qualitative study will inform the development of a supportive care program. A logical model framework will guide the program’s design, and expert consensus will be obtained using the Nominal Group Technique to validate its content, relevance, and feasibility.

Conclusion

This study aims to establish a conceptual framework for supportive care interventions. The resulting program may assist healthcare providers and policymakers in enhancing psychosocial outcomes and minimizing Parents and neonatal complications in this vulnerable population.

Background

Infertility is defined by the World Health Organization (WHO) as a disease of the male or female reproductive system, characterized by the inability to achieve pregnancy after 12 months or more of regular unprotected intercourse. It is recognized as a condition with profound social, economic, and psychological consequences for couples (Goker et al., 2018; WHO, 2020). Globally, an estimated 72.4 million couples are affected by infertility, with a reported prevalence ranging from 12% to 15% as of 2022 (Razeghi-Nasrabad & Abbasi-Shavazi, 2022). In response, assisted reproductive technologies (ART) have emerged as one of the most significant scientific breakthroughs, enabling many couples to achieve parenthood (Fertilisation & Authority, 2019). To date, more than 5 million children have been born worldwide through ART methods (Rengaraj et al., 2023). In line with demographic policies aimed at encouraging fertility, increasing numbers of infertile couples are turning to ART; however, pregnancies resulting from these methods are often associated with various physical and psychological complications for the mother, fetus, and newborn (Abbasi et al., 2005; Luke, 2017; Sullivan-Pyke et al., 2017). Even after a successful pregnancy is achieved, the emotional distress and anxiety stemming from the infertility journey often persist (Boz et al., 2018; Törenli Kaya, 2018). Maternal psychological stress can adversely affect not only the mother’s health but also fetal development and the child’s long-term outcomes (Allan, Mounce, et al., 2021; Mihelic et al., 2018). This situation can lead to social withdrawal and diminished quality of life and social well-being among these women (Huang et al., 2019).

Research has indicated that anxiety and depression levels in women who conceive through ART peak during the first trimester and the first two months postpartum, highlighting the need for strong social support during this critical period (Boz et al., 2021). Nevertheless, some studies suggest that postpartum depression rates in this group are not necessarily higher than those in women with spontaneous pregnancies (Listijono et al., 2014; West, 2014). Many women who successfully conceive following infertility treatments report finding profound meaning in their pregnancy experience, often grappling with a mix of joy and apprehension (Najafi et al., 2020; Sadeghi et al., 2019; Wittkowski et al., 2017). Pregnancy and the transition to parenthood are pivotal stages in the family life cycle, with men and women undergoing these experiences differently. Women who conceive through ART generally report higher levels of subjective well-being, whereas their male partners often experience elevated levels of psychological distress and concern (Albanese et al., 2019; Gameiro et al., 2010). Fathers’ anxieties regarding fetal health and pregnancy outcomes may contribute to decreased self-efficacy and heightened depressive symptoms, potentially hindering emotional bonding with the fetus (Allan, Van den Akker, et al., 2021; Hammarberg et al., 2008). Undoubtedly, motherhood following ART entails unique stressors and challenges, necessitating specialized psychological support for couples to navigate the complex biopsychosocial adjustments of this transition (Pinto et al., 2018; Sadeghi et al., 2019). Providing targeted support and care during pregnancy can lead to a more positive and fulfilling experience for these women (Lin et al., 2013). However, many couples face a disconnect between infertility services and maternity care, which can exacerbate their anxiety and sense of vulnerability (French et al., 2015; Maehara et al., 2022; Morgan, 2004).

The absence of national supportive policies and limited attention to the psychological and health needs of women pregnant via ART underscores the urgent need to identify their specific concerns and unmet needs (Foyston et al., 2022; Lehto et al., 2019; Warmelink et al., 2016, 2023). Therefore, conducting qualitative research to gain deeper insight into these experiences is vital, as it enables the development of culturally appropriate and evidence-based supportive care programs (Rene et al., 2022). The findings of such research can inform national health and population policies that align with the Iranian socio-cultural context and serve as an impetus to promote parenthood among infertile couples. In the current study, a grounded theory approach will be employed to explore the coping process in infertile couples who have conceived through ART, with the goal of designing a tailored supportive care program based on the emerging findings.

Objectives

1. To elucidate the process of infertile couples’ coping with successful treatment using ART methods.

2. To design a supportive care program for infertile couples who have achieved successful treatment using ART methods.

3. To validate the supportive care program for infertile couples with successful treatment using ART methods.

Methodology and Methods

The present study adopts the grounded theory approach as articulated by Corbin and Strauss (2015). This methodology is rooted in a particular worldview that shapes how individuals interpret their realities and informs the overall research design (Creswell & Plano Clark, 2007). The central research question is: “What is the process of infertile couples’ coping with successful treatment?” Addressing this question aims to deepen understanding of their lived challenges and enhance the quality of care provided to this population. This qualitative study is framed within a constructivist paradigm. The research ontology is based on relativism, while its epistemological stance is subjectivism. In qualitative inquiry, the objective is to explore and gain profound insight into phenomena through the lens of those who directly experience them (Creswell, 2007; Streubert & Carpenter, 2007).

Every research endeavor begins with the formulation of a guiding question and the selection of an appropriate methodology (Crespo & Bestard, 2016). Qualitative research is particularly well-suited for investigating complex, non-quantifiable phenomena, as it enables a deeper and more nuanced understanding of the subject through the lens of participants’ lived experiences (Creswell, 2007; Streubert & Carpenter, 2007). This study is grounded in the theoretical framework of Corbin and Strauss’s grounded theory (2015) and is informed by the philosophical foundation of symbolic interactionism—an interpretive perspective that emphasizes social interactions and the processes through which individuals construct meaning (Speziale & Carpenter, 2011). The primary aim is to address the research question concerning the coping process of infertile couples following successful treatment.

Rationale for Using Grounded Theory

Grounded theory investigates social processes within natural contexts and uncovers latent variables that influence behavior (Speziale & Carpenter, 2011, M et al., 2015, Heydari et al., 2020; Foley & Timonen, 2015). In this study, this methodology is employed to explore the psychosocial dynamics experienced by infertile couples during successful treatment. Considering the complexity of the phenomenon, cultural variability, and the tendency of couples to conceal infertility issues even after treatment success, grounded theory is particularly appropriate for revealing hidden and previously unknown realities (Behboodi-Moghaddam et al., 2013; Boz et al., 2021; Corbin & Strauss, 2014; Singh & Estefan, 2018; Zarif et al., 2020). It is also advocated in contexts where existing knowledge is limited and quantitative studies are insufficient (Mah, 2014). The researcher will establish rapport to gather rich, in-depth data and aims to construct a theory grounded in the Iranian cultural milieu regarding how infertile couples cope with successful treatment.

Research Setting

Interviews will be conducted in infertility centers, healthcare facilities, clinics, and specialists’ offices.

Participants

The study population comprises Iranian infertile couples who have successfully undergone ART treatments, with the woman either pregnant beyond 24 weeks of gestation or having delivered. Additionally, family members, specialists—including gynecologists, psychologists, and neonatologists—as well as center managers and other healthcare providers such as midwives and nurses will also participate.

Inclusion C Primary infertile couples who have achieved successful ART treatment, free from physical or mental conditions that would hinder participation in interviews, and who are willing to engage in the study. Variations in age, education, causes and types of infertility, ART methods, number of treatment cycles, and pregnancy or postpartum status will be taken into account.

Criteria

Primary infertile couples with successful ART treatment, without physical or mental illnesses that impede interview participation, and willing to engage in the study. Diversity in age, education, infertility causes, type of infertility, ART method, number of treatment attempts, and pregnancy or postpartum status will be considered.

Participant Selection and Sample Size

Sampling will be purposeful and theoretical, focusing on individuals with pertinent experience (Mah, 2014). Data collection will commence, with ongoing analysis directing the refinement of research questions until data saturation is reached (Adib Hajbagheri et al., 2004). Theoretical sampling in grounded theory depends on emerging concepts and their interrelations from the data (Corbin & Strauss, 2014). In this study, samples will be chosen to ensure maximum variation in age, education, causes and types of infertility, ART method, duration of infertility, and pregnancy status. The estimated sample size is around 30 couples, continuing until saturation is achieved.

Implementation Method

This study will be conducted in two consecutive phases. The first phase is a qualitative grounded theory study based on Corbin and Strauss’s method (2015). The second phase involves designing a supportive care program based on the qualitative findings and related studies.

Phase One: Study

Following ethical approval and sampling authorization, the researcher will visit designated sampling centers. Prior to interviews, the study objectives will be thoroughly explained, and informed consent will be obtained. Interview schedules and locations will be coordinated with participants’ preferences. The researcher will be present throughout the interviews, recording detailed field notes capturing key points, observations, nonverbal behaviors, and participant reactions. Any uncertainties will be addressed through informal discussions and supplementary interviews.

Data Collection Method

Grounded theory research employs multiple techniques such as observation, individual and group interviews, and reflective note-taking to gather comprehensive data, with semi-structured, in-depth interviews featuring open-ended questions as the primary instrument (Adib-Hajbaghery et al., 2015; Behboodi-Moghaddam et al., 2013; Boz et al., 2021; Corbin & Strauss, 2014; Mah, 2014; Peters, 2023; Polit & Beck, 2008; Singh & Estefan, 2018; Zarif et al., 2020). Interviews will be adapted dynamically according to participants’ responses through probing questions and may occur over single or multiple sessions. Participants will complete a demographic questionnaire prior to interviews. Interviews will initiate with broad questions such as “Describe your experience upon learning of your pregnancy” and progressively focus on more specific inquiries like “Explain your experience of the first fetal movement” or “Discuss the day you first held your child.” Clarification and probing will be employed to deepen understanding of emerging concepts. At the conclusion, participants may amend or supplement their statements. Additional interviews will also be conducted with family members and key stakeholders.

Interview Location and Duration

Interviews will be conducted at infertility centers in Mashhad (Milad, Novin, Razavi, Armaghan, Rayan), healthcare centers in Mashhad and Isfahan, clinics, and specialists’ offices, depending on participant convenience and consent. Each interview will last approximately 45 to 60 min, with flexibility for extension based on participant agreement. Audio recordings will be made with permission, and nonverbal cues documented through detailed notes. Participants will be thanked at the end, and any potential follow-up interviews will be communicated.

Field and Contextual Notes

In addition to interviews, field notes will capture nonverbal behaviors, participant reactions, and contextual factors to enrich data analysis (Hodkinson, 2008; Sanger, 2002). These notes will be completed promptly after each interview, with emergent ideas and interpretations systematically recorded.

Ethical Considerations

The research objectives will be communicated to the center officials, and observations will be conducted using the full observer method after obtaining consent. This study will receive an ethics approval code from the relevant organization. Prior to initiating the research process, written informed consent will be obtained from all participants. In cases where audio recording or note-taking is required, participants will be informed in advance, and these will only proceed with their explicit consent. Furthermore, all personal information and collected data will be kept confidential and used solely for research purposes, in strict adherence to privacy and confidentiality principles.

Data Analysis Method

In this study, data analysis will be conducted concurrently and iteratively with data collection, following the systematic approach of Corbin and Strauss (2015) and grounded in the principles of symbolic interactionism. This cyclical process will allow emerging insights to shape subsequent data collection, enhancing the researcher’s theoretical sensitivity and enabling a deep, nuanced exploration of the phenomena under investigation. Such an approach ensures that the evolving analysis remains grounded in participants’ lived experiences while progressively developing toward theoretical abstraction. The open coding phase will begin immediately after each interview, with audio recordings transcribed verbatim. These transcripts, along with detailed field notes, will be read multiple times to gain a holistic understanding before assigning codes. Data will be examined line-by-line, segmented into discrete meaning units, and assigned both conceptual and interpretive codes. This step marks the transition from raw, descriptive information to the first level of abstraction. All codes will be managed using MAXQDA 2010 software to ensure systematic organization, efficient retrieval, and cross-referencing throughout the analytic process.

In this study, data collection and analysis will be conducted simultaneously and continuously from the outset of the research. The analysis will follow the grounded theory approach proposed by Corbin and Strauss (2015), which comprises five key stages: (1) extracting concepts from the data, (2) developing concepts in terms of their properties and dimensions, (3) analyzing data within their contextual background, (4) incorporating process into the analysis, and (5) integrating categories. Consistent with Corbin and Strauss’s (2015) methodology, analytical techniques such as sensitizing and theoretical questions, constant and theoretical comparisons, the Flip-flop technique, and the “waving the red flag” approach will be employed to examine the data with respect to context, process, and category integration. These strategies will ensure a precise and comprehensive understanding of the phenomena under study (Corbin & Strauss, 2015).

Ensuring Rigor in Qualitative Analysis

To enhance the credibility of this study, strategies such as prolonged engagement with the research setting, triangulation of data sources (interviews, field notes, and memos), and member checking will be employed. In this process, preliminary findings and interpretations will be shared with selected participants to verify the accuracy and validity of the researcher’s interpretations. These measures will ensure that the insights obtained genuinely reflect participants’ lived experiences. Transferability will be ensured by providing thick, rich descriptions of participants’ experiences, contexts, and individual and social characteristics, enabling readers to identify comparable settings and assess the applicability of the findings. Furthermore, dependability will be achieved by creating and maintaining a comprehensive audit trail that documents all methodological decisions, changes in data collection approaches, and iterative coding processes. Peer debriefing with qualitative research experts will also contribute to the stability and consistency of the coding. To ensure confirmability, the researcher will maintain reflective journals to identify and bracket personal assumptions and biases, and systematically document how actual data—rather than personal preferences—guided the development of categories and the emergent theory. By integrating these rigor-enhancing strategies throughout the analysis process, the study will not only generate a grounded theory based on participants’ lived experiences but also produce findings that are credible, dependable, transferable, and free from researcher bias within the socio-cultural context of the Iranian health system (Corbin and Strauss, 2008, 2015).

Phase Two: Supportive Care Program Development

In the second phase, the supportive care program will be developed using a structured approach based on the Logic Model framework. This model provides a systematic structure that links identified needs to specific resources, planned activities, measurable outputs, and intended short- and long-term outcomes. Drawing from the findings of the first phase, the program will be tailored to the psychological, emotional, informational, and social support needs of couples who have undergone successful assisted reproductive treatment (ART). The Logic Model will serve as a roadmap for designing the program’s components, including inputs (e.g., human and organizational resources), activities (e.g., counseling sessions, educational interventions), outputs (e.g., number of sessions or materials delivered), and outcomes (e.g., enhanced quality of life, strengthened family support).

To ensure the program’s relevance, feasibility, and scientific validity, expert consultation will be sought through the Nominal Group Technique (NGT). This structured consensus-building method will involve reproductive health professionals, psychologists, social workers, and other relevant stakeholders. Participants will engage in successive rounds of idea generation, discussion, and ranking to evaluate and refine the proposed components of the program. The use of NGT will ensure that the final program reflects expert consensus, is culturally appropriate, and meets the practical needs of the target population. This validation process will strengthen the credibility and applicability of the supportive care model for future implementation in clinical and community settings.

Discussion

Explaining the process by which infertile couples cope with treatment success through assisted reproductive technologies (ART) requires a deep, comprehensive understanding of the psychological, social, and identity changes these couples undergo during the transition from infertility to parenthood. Although treatment success marks a hopeful milestone, it also brings new complexities (Luke, 2017; Sullivan-Pyke et al., 2017). This phase involves mixed, conflicting emotions such as joy, anxiety, doubt, fear of recurrence, alongside societal pressures and cultural expectations. Coping with these conditions extends beyond physical and medical support and demands profound insight into couples’ lived experiences as they interact with each other, their families, healthcare providers, and the broader sociocultural context (Allan, Mounce, et al., 2021; Mihelic et al., 2018). In this context, grounded theory offers the opportunity to generate a locally adapted theory explaining this complex process within real-life experiences. Designing a supportive-care program based on qualitative data is a fundamental step toward addressing neglected needs of this group (Huang et al., 2019). Such a program must fill gaps in healthcare and support couples throughout pregnancy, childbirth, and the transition to parenthood by focusing on emotional, psychological, cultural, and educational dimensions (Boz et al., 2021).

Moreover, including active participation and experiences of men—often overlooked in research—can greatly contribute to balancing parental roles and enhancing family quality of life (Listijono et al., 2014). Designing the program based on the derived theory not only improves person-centered care but also aids in developing more effective policies, better training for health professionals, and increased satisfaction among service users (West, 2014). For example, Boz et al. (2021), using grounded theory, explored women’s experiences transitioning to motherhood after successful IVF and identified four main stages. However, their study focused only on women and a limited timeframe, neglecting social interactions and partners’ perspectives. In contrast, the present study includes infertile couples, families, and healthcare providers, covering pregnancy to six months postpartum, thus providing richer data (Boz et al., 2021). Similarly, Allan, Mounce, et al., 2021 conducted a qualitative UK study with 16 infertile couples and identified three themes: “preparing for parenthood,” “becoming parents,” and “planning for a second child.” Although highlighting identity complexities post-IVF, their study was limited to early postnatal period (Sadeghi et al., 2019). In Iran, Sadeghi et al. (2019), using a phenomenological approach, identified the “over-challenged mother” theme from mothers with children aged 9 months to 7 years. Yet paternal roles and social interactions remained underexplored. The present study, employing grounded theory with a broader temporal scope, examines couples’ experiences within social environments (Allan, Mounce, et al., 2021).

In another study, Crespo & Bestard, 2016 in Spain emphasized psychosocial challenges including anxiety, contradictory emotions, and restricted emotional expression after ART. The current study, with diverse participants in infertility types and treatment stages, offers deeper insight into these experiences (Crespo & Bestard, 2016). Additionally, West (2014) used a logic model to develop a community-based diabetes prevention program. Comparatively, this study aims to design a supportive-care program for ART-treated couples based on qualitative findings and literature review (West, 2014). Likewise, Najafi et al. (2020), employing grounded theory and a logic model, developed a care program for women during childbirth; however, the present study focuses specifically on ART-treated infertile couples and their unique needs (Najafi et al., 2020).

Despite many studies on parenthood post-ART, no research has specifically addressed coping with treatment success or developed a grounded theory in this area (Boz et al., 2021; Listijono et al., 2014; Najafi et al., 2020; Sadeghi et al., 2019; West, 2014; Wittkowski et al., 2017). Most focus on women, leaving men’s experiences largely unexplored. Yet male involvement plays a crucial role in reducing anxiety, improving psychological adjustment, and enhancing acceptance of parental roles (Allan, Mounce, et al., 2021; Boz et al., 2021; West, 2014). Parental identity in these couples forms within individual, family, societal, and healthcare system contexts (Najafi et al., 2020). Therefore, a deep, multifaceted exploration using grounded theory is essential (French et al., 2015; Maehara et al., 2022). Several studies have also noted care gaps from treatment success through postpartum (Lehto et al., 2019; Warmelink et al., 2023). Accordingly, this study aims to develop a grounded theory explaining how infertile couples cope with successful treatment and subsequently design a structured supportive-care program based on findings (Foyston et al., 2022; Rene et al., 2022). The results are expected to yield a localized, comprehensive, practical model for supportive care of successfully treated infertile couples.

Limitations

One of the main limitations of this study is the possible unwillingness of some participants to openly share their lived experiences regarding infertility treatment and pregnancy. This reluctance may arise from the sensitive nature of the subject, feelings of shame, fear of judgment, or distrust of the researcher’s intentions, all of which can affect the quality and depth of qualitative data. To address this challenge, strategies such as clearly explaining the study’s objectives, ensuring confidentiality, creating a safe and nonjudgmental environment, and building empathetic and trusting relationships with participants will be used. Additionally, considering the unique physical and psychological conditions of mothers after successful ART treatment and the need for rest during early pregnancy, conducting interviews at the couples’ homes will be necessary. Although this method increases participants’ comfort and sense of security, it may present logistical, ethical, and cultural challenges for the researcher in managing time and navigating private family spaces. To overcome this, interviews will be carefully scheduled in advance, with full ethical consideration and respect for families’ privacy.