Department of Family Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Elisabeth Bruyère Research Institute, Ottawa, Ontario, Canada.
BMJ Open. 2019 May 27;9(5):e028496. doi: 10.1136/bmjopen-2018-028496.
Ovulation confirmation is a fundamental component of the evaluation of infertility.
To inform the design of a larger clinical trial to determine the effectiveness of a new home-based pregnanediol glucuronide (PDG) urine test to confirm ovulation when compared with the standard of serum progesterone.
In this observational prospective cohort study (single group assignment) in an urban setting (stage 1), a convenience sample of 25 women (aged 18-42 years) collected daily first morning urine for luteinisinghormone (LH), PDG and kept a daily record of their cervical mucus for one menstrual cycle. Serum progesterone levels were measured to confirm ovulation. Sensitivity and specificity were used as the main outcome measures. Estimation of number of ultrasound (US)-monitored cycles needed for a future study was done using an exact binomial CI approach.
Recruitment over 3 months was achieved (n=28) primarily via natural fertility regulation social groups. With an attrition rate of 22%, specificity of the test was 100% for confirming ovulation. Sensitivity varied depending on whether a peak-fertility mucus day or a positive LH test was observed during the cycle (85%-88%). Fifty per cent of participants found the test results easy to determine. A total of 73 US-monitored cycles would be needed to offer a narrow CI between 95% and 100%.
This is first study to clinically evaluate this test when used as adjunct to the fertility awareness methods. While this pilot study was not powered to validate or test efficacy, it helped to provide information on power, recruitment and retention, acceptability of the procedures and ease of its use by the participants. Given this test had a preliminary result of 100% specificity, further research with a larger clinical trial (stage 2) is recommended to both improve this technology and incorporate additional approaches to confirm ovulation.
NCT03230084.
排卵确认是不孕评估的基本组成部分。
为一项更大规模临床试验的设计提供信息，以确定一种新的基于家庭的孕二醇葡萄糖醛酸（PDG）尿检测在确认排卵方面的有效性，该检测方法与血清孕激素标准相比。
在这项观察性前瞻性队列研究（单组分配）中，选择了一个城市环境（第 1 阶段）的便利样本，25 名年龄在 18-42 岁的女性每天采集第一次晨尿进行黄体生成素（LH）、PDG 检测，并记录一个月经周期的宫颈黏液的日常情况。通过测量血清孕激素水平来确认排卵。以敏感性和特异性作为主要结局指标。使用精确二项式 CI 方法估算未来研究所需的超声（US）监测周期数。
通过自然生育调节社会群体，在 3 个月内完成了招募（n=28）。由于脱落率为 22%，该检测方法对确认排卵的特异性为 100%。敏感性取决于在周期中是否观察到高峰期生育黏液日或阳性 LH 检测（85%-88%）。50%的参与者认为该检测结果易于确定。需要进行总共 73 次 US 监测周期，才能在 95%和 100%之间提供狭窄的 CI。
这是首次将该检测方法作为生育意识方法的辅助手段进行临床评估的研究。虽然这项初步研究没有足够的能力来验证或测试疗效，但它有助于提供关于效能、招募和保留、程序的可接受性以及参与者使用的简便性方面的信息。鉴于该检测方法的特异性初步结果为 100%，建议进行更大规模的临床试验（第 2 阶段），以进一步改进该技术并纳入其他确认排卵的方法。
NCT03230084。
