This systematic review aims to synthesize the evidence on infertility interventions, policies, and regulatory frameworks, as well as their availability and accessibility constraints amongst individuals and couples especially in LMICs. Our research questions are:
- What are the types of infertility interventions?
- What are the key challenges in the design and implementation of interventions?
- How accessible and available are infertility interventions?
- What are the outcomes of infertility interventions and how are these outcomes measured?
- What policies or regulation frameworks exist to address infertility?
The estimation of the global burden of infertility is often challenging. This is attributable in part, to global disparities in the definition of infertility, socio-cultural constructions of infertility which may foster underreporting, as well as variances in the tools and methods used in the measurement of infertility 3,13. With respect to interventions, disparities may exist in their definitions and characterization, especially in LMIC contexts where non-clinical methods may be popular among infertile people due to widespread challenges in accessing clinically approved standardized infertility treatments 14. These non-clinical interventions may include herbal/traditional treatments, religious/spiritual procedures, culturally approved surrogacies or adoptions or any combination of these 15–18. The availability, desirability and success of interventions are also dependent on several personal and socio-political factors which include but may not be limited to social pressures to biologically bear children, especially in pro-natalist populations 19, the availability of personal funds to access often-times expensive interventions without incurring catastrophic expenditure 20,21, and the geographical spread of services and facilities within countries 22. In addition to these personal and social factors, understanding of health policy and systems factors that mediate access, treatment, and management options is paramount in investigations to better understand infertility interventions and effectively address their constraints.
In this research, we seek to answer questions on the “what”: what the issue is, what interventions are available to mitigate it, what are the results, and what are the possible challenges with the currently available remedies. We further seek to identify at the systemic and individual levels what is available in terms of services, programmes and policies that are currently in use for mitigating infertility. Finally, we seek to know what the multi-level challenges are with available FP interventions that address infertility, and how they ultimately affect intervention results.
Our findings will be used to develop a framework to assist in program design and implementation especially in LMICs. A synthesis of the types of interventions available in these contexts will also be conducted. A conceptualization of the challenges; individual, socio-political and health system that face infertility interventions, also forms an integral portion of our proposed review.
This review will help shape future FP and other programs aimed at addressing infertility by underscoring the magnitude of the often-ignored problem of infertility, provide a context and framework for policy development and help identify the individual and socio-political implications of programming challenges.
Review Methods
We will synthesize both quantitative and qualitative research that investigates primary as well as secondary infertility. The quantitative studies are aimed at estimating the burden of infertility since 1960, which marks a period of widespread concern about rapid global population growth and the onset of organised family planning interventions in LMICs. Our review of the included studies will conceptualize the narrative around personal and socio-cultural constructs of infertility, available interventions and their related challenges. We shall also review evidence on the evaluations of these interventions and their outcomes at individual and population levels as well as the related challenges. This review protocol is registered in PROSPERO with code CRD42019130784.
Inclusion criteria
- Primary qualitative and quantitative research studies that examine any type of infertility i.e. primary and secondary among both men and women
- Observational & experimental study designs (cross-sectional, case-control studies, cohort studies, randomized control trials)
- Studies conducted in low and middle-income countries (LMICs)
- Published between January 1960 and December 2020.
- Published in English.
Exclusion criteria
- Studies that do not focus on infertility as a primary research objective.
- Editorials, commentaries, case reports, and brief reports on family planning
Information Sources
We will conduct searches of MeSH terms and combined words in major electronic journal databases that report on FP and infertility issues such as PubMed, Medline, EMBASE, CINHAL, POPLINE, Web of Science, African Medicus, Google Scholar and HINARI. We shall also conduct grey literature searches in relevant organizational websites such as WHO, UNFPA, IPPF, Population Council, and PSI.
Search Strategy
Our search strategy will be implemented across all databases. The search strings are attached as Appendix 1.
Screening
Screening across databases will be conducted with a custom-developed Ms-Excel tool created specifically for the purpose of this review. Two reviewers will conduct title and abstract screening in the first stage. At the next stage, two reviewers will screen full text to identify included studies. A third reviewer will provide inputs to resolve any disagreements and to finalize selection at both levels of screening. The study selection process will be carried out according to the preferred reporting items for systematic review and meta-analysis (PRISMA) flow diagram. The reason for the exclusion the of any study will be described in detail.
Appraisal
All selected full-text studies will be assessed for their quality using the Joanna Briggs Institute (JBI) critical appraisal checklist suitable for each methodological design. All papers will be independently appraised by two reviewers in duplicate. A third reviewer will have the responsibility of resolving any disparities between the two independent appraisals.
Extraction
The extraction of studies will be conducted using a specially developed Ms-Excel extraction template. The template will have sections which will be populated with data including author, year of publication, country, study design and reported prevalence of infertility. Detailed information on any interventions or policies will also be collected including the overseeing body, the target, dosage, and theoretical underpinning. Additionally, we shall draw information on key findings, conclusions, limitations, and recommendations of the studies. Appendix 2 is a representation of the extraction tool. Extraction will be conducted independently by two reviewers.
Analysis
The data will first undergo a narrative synthesis of the included studies. A summary table will be developed to describe the study characteristics of the included articles. A thematic analysis of the studies will then be conducted on the included qualitative studies to characterize the spectrum of infertility interventions, and their accessibility and availability in LMICs. We shall also thematize the key design, implementation and evaluation challenges with respect to these interventions. The documented individual, population-level and health system outcomes of these interventions will also be thematically analyzed. Also included in the analyses will be the existing political and regulatory frameworks within which these interventions are situated and operate. Studies which are deemed suitable for quantitative synthesis will undergo meta-analysis. This will be conducted using a random-effects model in a suitable software application (CMA, RevMan, STATA or R). Studies without a quantitative component and are thus unsuitable for meta-analyses will only undergo qualitative synthesis.