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Abstract
Background: Assessing menstrual cycle function in the general population using a non-invasive method is challenging, both in non-industrialized and industrialized countries.
Subjects and methods: The Observatory of Fecundity in France (Obseff) recruited on a nationwide basis a random sample of 943 women aged 18–44 years with unprotected intercourse. A sub-study was set up to assess the characteristics of a menstrual cycle by using a non-invasive method adapted to the general population. Voluntary women were sent a collection kit by the post and requested to collect urine samples on pH strips, together with daily recording of reproductive-related information during a full menstrual cycle. A total of 48 women collected urine every day, whereas 160 women collected urine every other day. Immunoassays were used to measure pregnanediol-3–α–glucuronide, estrone-3-glucuronide and creatinine. Ovulation occurrence and follicular phase duration were estimated using ovulation detection algorithms, compared to a gold standard consisting of three external experts in reproductive medicine.
Results: Every other day urine collection gave consistent results in terms of ovulation detection with every day collection (intraclass coefficient of correlation, 0.84, 95% confidence interval, 0.76–0.98). The proportion of anovulatory menstrual cycles was 8%. The characteristics of the ovulatory cycles were length 28 (26–34), follicular phase 16 (12–23), luteal phase 13 (10–16) days median (10th–90th percentiles).
Discussion-Conclusion: Assessing menstrual cycle characteristics based on urine sample spot only collected every other day in population-based studies through a non-invasive, well accepted and cost-limited procedure not requiring any direct contact with the survey team appears feasible and accurate.
Chinese abstract
背景：用非侵入性方法评估普通人群的月经周期功能在非工业化国家和工业化国家都具有挑战性。
研究对象和方法：法国生殖研究所（Obseff）在全国范围内随机招募了943名年龄在18-44岁且无保护性交的女性, 通过用适合一般人群的非侵入性方法来建立一个评估月经周期特征的子研究。志愿者妇女在招募点收到一个采集盒, 要求在pH试纸条上收集尿液样本, 并在每个月经周期内记录每天的生殖相关信息。共有48名妇女每天收集尿液, 而160名妇女每隔一天收集一次尿液。用免疫测定法测定孕二醇-3-α-葡糖苷酸, 雌酮-3-葡糖苷酸和肌酸酐, 使用排卵检测法估计排卵发生和卵泡期持续时间, 与由三位外部生殖专家组成的黄金标准进行比较。
结果：每隔一天的尿液收集在排卵检测方面与每天收集的结果是一致的（组内相关系数0.84, 95％置信区间0.76-0.98）。无排卵月经周期比例为8％, 排卵周期的特征是长度28天（26-34）, 卵泡期16天（12-23）, 黄体期13天（10-16）, 中位数（第10至第90百分位）。
讨论-结论：基于人群的研究样本中, 通过非侵入性的、广泛接受的和成本有限的每隔一天收集尿液样本的程序来评估月经周期特征, 而不要求患者与调查组直接接触, 这似乎是可行和准确的。
Author contributions
LR and JCT contributed equally to this work. RS, JB and LR initiated the study. LR, BD, JB, AB, JCT and RS designed the study, LR and AC prepared the booklets and kits. LR, BD, AB and AC implemented the study and supervised data collection and management. AC carried the laboratory work under the supervision of LR. JCT prepared the blind review of the hormonal profiles, which were analysed by LMM, CRJ. Data analysis was performed by JCT and JT. LR and JCT drafted the first version of the manuscript. JT, BD, LMM, CRJ, JB, AB, AC and RS critically reviewed the manuscript.
Acknowledgements
The authors wish to thank Prof. G Plu-Bureau who participated to the blind assessment of the urinary profiles. They express their gratitude to the women who accepted to participate to the study and comply with the burden of the protocol.
Disclosure statement
The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.