Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM Study)

Bruyère Health Research Institute.

Status

Enrolling

Conditions

Cervical Mucus

Progesterone

Fertility

Luteinizing Hormone (LH)

Body Temperature

Menstrual Cycle

Artifical Intelligence

Ovulation

Mobile Applications

Treatments

Other: Premom App-Assisted Fertility Tracking

Study type

Observational

Funder types

Other

Identifiers

NCT07248046

REB-2026-56

Details and patient eligibility

About

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.

Full description

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.**

Enrollment

30 estimated patients

Sex

Female

Ages

16 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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