STUDY QUESTION Does the prevalence of 12-month infertility in Burkina Faso, Côte d’Ivoire, Kenya, and Uganda differ between women trying to conceive and the broader population of women exposed to unprotected sex, and how are prevalence estimates affected by model assumptions and adjustments? SUMMARY ANSWER Estimates of 12-month infertility among tryers ranged from 8% in Burkina Faso to 30% in Côte d’Ivoire, increasing substantially among a larger population of women exposed to unprotected intercourse. WHAT IS KNOWN ALREADY While having a child is a fundamental human experience, the extent to which women and couples experience infertility is a neglected area of research, particularly in sub-Saharan Africa. Existing estimates of infertility in this region vary widely from 2% to 32%, however, potential impacts of variability in study populations and model assumptions have not been well-examined. STUDY DESIGN, SIZE, DURATION We used cross-sectional nationally representative survey data from Burkina Faso, Côte d’Ivoire, Kenya, and Uganda. We employed a multi-stage cluster random sampling design with probability proportional to the size selection of clusters within each country to produce representative samples of women aged 15–49. Samples ranged from 3864 in Côte d’Ivoire to 9489 in Kenya. PARTICIPANTS/MATERIALS, SETTING, METHODS We created two analytic samples in each country—tryers and a broader sample of women exposed to unprotected sex—exploring differences in population characteristics and estimating the period prevalence of 12-month infertility using the current duration (CD) approach. We also examined the impact of several model assumptions within each of the two analytic samples, including adjustments for recent injectable contraceptive use, unrecognized pregnancy, infertility treatment, underreported contraceptive use, and sexual activity. MAIN RESULTS AND THE ROLE OF CHANCE Employing the CD approach among tryers produced an overall 12-month infertility prevalence of 7.9% (95% CI 6.6–12.7) in Burkina Faso, 29.6% (95% CI 15.3–100.0) in Côte d’Ivoire, 24.5% (95% CI 16.5–34.6) in Kenya, and 14.7% (95% CI 8.1–22.4) in Uganda. Results among women exposed to unprotected intercourse indicated much higher levels of infertility, ranging from 22.4% (95% CI 18.6–30.8) in Uganda to 63.7% (95% CI 48.8–87.9) in Côte d’Ivoire. Sensitivity analyses suggest infertility estimates are particularly sensitive to adjustments around pregnancy recognition timing and sexual activity, with little impact of adjustments for recent injectable contraceptive use, infertility treatment, and underreporting of traditional and coital dependent contraceptive use. LIMITATIONS, REASONS FOR CAUTION There was substantial digit preference in responses at 12 months, particularly among the tryers, which could introduce bias. Data quality concerns in the reproductive calendar may impact the accuracy of the CD approach among the broader sample of women exposed to unprotected sex, particularly with regard to underreported contraceptive use, induced and spontaneous abortions, and unrecognized pregnancies. Lastly, we lacked information on postpartum amenorrhea or abstinence. WIDER IMPLICATIONS OF THE FINDINGS Understanding the inconsistencies in definition and analytic approach and their implications for infertility estimation is important for reliably monitoring population-level infertility trends, identifying factors influencing infertility, improving prevention programs, and ensuring access to quality treatment and services. STUDY FUNDING/COMPETING INTEREST(S) This study was supported by grants from the Bill & Melinda Gates Foundation (INV009639) and the National Institute of Child Health and Human Development (K01HD107172). The funders were not involved in the study design, analyses, manuscript writing, or the decision to publish. The authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER N/A.

中文翻译：

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测量非事件：使用来自撒哈拉以南非洲四个国家的基于人群的横断面数据估计不孕症


研究问题 在布基纳法索、科特迪瓦、肯尼亚和乌干达，12 个月不孕症的患病率在试图怀孕的女性和更广泛的暴露于无保护性行为的女性群体之间是否不同，以及模型假设和调整如何影响患病率估计？摘要答案 据估计，试验者 12 个月不孕症的发生率从布基纳法索的 8% 到科特迪瓦的 30% 不等，在暴露于无保护的较大女性群体中大幅增加。已知的虽然生孩子是人类的基本经历，但女性和夫妇不孕不育的程度是一个被忽视的研究领域，尤其是在撒哈拉以南非洲。该地区现有的不孕症估计差异很大，从 2% 到 32% 不等，但是，研究人群和模型假设的可变性的潜在影响尚未得到充分检验。研究设计、规模、持续时间 我们使用了来自布基纳法索、科特迪瓦、肯尼亚和乌干达的具有全国代表性的横断面调查数据。我们采用多阶段整群随机抽样设计，概率与每个国家/地区的聚类选择规模成正比，以产生 15-49 岁女性的代表性样本。样本范围从科特迪瓦的 3864 个到肯尼亚的 9489 个不等。参与者/材料、环境、方法 我们在每个国家/地区创建了两个分析样本——试验者和更广泛的暴露于无保护性行为的女性样本——探索人口特征的差异并使用当前持续时间 （CD） 方法估计 12 个月不孕症的患病率。 我们还检查了两个分析样本中每个样本中几个模型假设的影响，包括对近期注射避孕药具使用、未被发现的怀孕、不孕症治疗、漏报避孕药具使用和性活动的调整。主要结果和机会的作用在尝试者中采用 CD 方法的总体 12 个月不孕症患病率为 7.9% （95% CI 6.6-12.7），科特迪瓦为 29.6% （95% CI 15.3-100.0），肯尼亚为 24.5% （95% CI 16.5-34.6），乌干达为 14.7% （95% CI 8.1-22.4）。暴露于无保护的妇女的结果表明，不孕症的发生率要高得多，从乌干达的 22.4% （95% CI 18.6-30.8） 到科特迪瓦的 63.7% （95% CI 48.8-87.9） 不等。敏感性分析表明，不孕症估计值对妊娠识别时间和性活动的调整特别敏感，对近期注射避孕药具的使用、不孕症治疗以及传统和依赖性避孕药具使用的低报调整影响不大。局限性，谨慎的原因 在 12 个月时，反应中存在大量的数字偏好，尤其是在尝试者中，这可能会引入偏倚。生殖日历中的数据质量问题可能会影响 CD 方法在暴露于无保护性行为的更广泛样本中的准确性，特别是在漏报的避孕药具使用、人工流产和自然流产以及未识别的怀孕方面。最后，我们缺乏有关产后闭经或戒断的信息。 研究结果的更广泛影响 了解定义和分析方法的不一致及其对不孕症估计的影响，对于可靠地监测人群水平的不孕症趋势、确定影响不孕症的因素、改进预防计划以及确保获得优质治疗和服务非常重要。研究资金/竞争利益 这项研究得到了比尔和梅琳达·盖茨基金会（INV009639）和国家儿童健康与人类发展研究所（K01HD107172）的资助。资助者没有参与研究设计、分析、手稿写作或发表决定。作者没有需要声明的利益冲突。试验注册号 N/A。