Comparing Cervical Mucus, PDG, LH, and Basal Body Temperature Combinations for Ovulation and Luteal Phase Identification Using the Premom Smartphone App Versus User-Read Test Results: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Agreement Between Marker Combinations and the Estimated Day of Ovulation (EDO)
研究概览
简要总结
This study will compare different combinations of fertility signs (cervical mucus (CM), luteinizing hormone [LH], pregnanediol glucuronide [PDG], and basal body temperature [BBT]) to determine which are most reliable for identifying ovulation and luteal phase length. Thirty existing Premom App users will track daily observations for three menstrual cycles. Participants will record mucus, perform urine tests, upload test strip photos to the Premom App, and measure BBT. Both participant readings and AI-assisted app readings will be analyzed. The main goal is to find which marker pairings give the most accurate picture of ovulation timing and luteal phase length. Secondary goals include understanding ease of use, the number of tests required, and whether the app improves accuracy.
详细描述
This study examines how well different combinations of fertility signs-cervical mucus changes, hormone levels in urine, and body temperature-can help identify ovulation and luteal phase length. The study uses the Premom App, which allows users to record fertility signs and take photos of urine hormone test strips for AI-assisted interpretation. Four marker pairs will be compared: Mucus plus PDG, LH plus PDG, Mucus plus BBT, and LH plus BBT. Each participant will track three cycles, with both app-based and user-based readings analyzed. The study will assess which marker pairings are most accurate and user-friendly. Secondary endpoints include usability, test burden, and app vs. participant agreement. Results may support improvements in fertility awareness and digital health tools. Risks are minimal and involve time commitment for daily tracking. **This is an observational study. Participants are not assigned to any intervention; all fertility signs collected are part of their existing self-tracking using the Premom App. The study analyzes these naturally occurring data to compare marker pairings for identifying ovulation and luteal phase length.**
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 16 to 45
- •Natural menstrual cycles equal or less than 35 days
- •Off hormonal contraception for more than 3 months
- •Current user of the Premom App
- •Willing to track cervical mucus, LH, PDG, and BBT for 3 full cycles
- •Lives within 50 km of study site in the Ottawa region
- •Able to provide informed consent
排除标准
- •Pregnant or breastfeeding
- •Current hormonal therapy or contraception
- •Known anovulatory disorders, e.g., Polycystic Ovary Syndrome, hypothalamic amenorrhea.
- •Very irregular or absent cycles
- •Not using the Premom App
- •Unable or unwilling to complete tracking or provide consent
研究组 & 干预措施
Premom App Users
Women aged 16 to 45 already using the Premom App, who will track daily fertility signs over 3 menstrual cycles.
干预措施: Premom App-Assisted Fertility Tracking (Other)
结局指标
主要结局
Agreement Between Marker Combinations and the Estimated Day of Ovulation (EDO)
时间窗: Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant
This outcome evaluates how four fertility marker combinations identify the Estimated Day of Ovulation (EDO) across three menstrual cycles. Participants will record daily cervical mucus (CM) observations, urinary luteinizing hormone (LH) and pregnanediol glucuronide (PDG) results, and basal body temperature (BBT), using both manual readings and the Premom smartphone app. For each cycle, the EDO will be established using validated physiologic indicators, including peak-type cervical mucus, the LH surge, the rise in PDG, and the post-ovulatory BBT shift. The EDO identified by each marker combination-cervical mucus plus PDG, LH plus PDG, cervical mucus plus BBT, and LH plus BBT. Agreement will be assessed by calculating the absolute day-difference between estimates.
Luteal Phase Length Determined by Different Fertility Marker Combinations
时间窗: Daily tracking through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.
Number of days from the estimated day of ovulation to the onset of the next menstrual period, calculated for each marker combination and compared within subjects across three menstrual cycles.
次要结局
- User Satisfaction with Fertility Tracking Methods(At completion of Cycle 3 (cycle length up to 35 days).)
- Agreement Between Participant and App Interpretations of LH and PDG Test Strips(At completion of Cycle 3 (cycle length up to 35 days).)
- Testing Burden and Number of Testing Days per Cycle(Daily tracking Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.)
- App Usability and Functionality Evaluation(At completion of Cycle 3 (cycle length up to 35 days).)
- Correlation Between Cervical Mucus-Defined and Standard Fertile Window(Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.)
研究者
Rene Leiva
Principal Investigator
Bruyère Health Research Institute.