Smartphone versus manual reading of fertility signs to find ovulation and luteal phase
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
This project will test whether a smartphone app's AI reading of cervical mucus, urine hormone strips, and basal body temperature gives as accurate ovulation and luteal phase timing as manual readings for people tracking fertility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | Female |
| Sponsor | Bruyère Health Research Institute. Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07248046 on ClinicalTrials.gov |
What this trial studies
This observational study asks 30 existing Premom App users to record cervical mucus, take daily LH and PDG urine tests, and measure basal body temperature across three menstrual cycles. Participants will upload photos of test strips to the Premom App and also record their own manual interpretations so AI-assisted app readings can be compared with participant readings. Four marker pairings (mucus+PDG, LH+PDG, mucus+BBT, LH+BBT) will be analyzed to determine which combinations best identify ovulation timing and luteal phase length. Secondary outcomes include usability, test burden, and agreement between app and participant interpretations.
Who should consider this trial
Good fit: People aged 16–45 with natural menstrual cycles ≤35 days, off hormonal contraception ≥3 months, who are current Premom App users and willing to track mucus, LH, PDG, and BBT for three full cycles are ideal candidates.
Not a fit: Those who are pregnant or breastfeeding, on hormonal contraception or therapy, have known anovulatory disorders or very irregular/absent cycles, or cannot use the Premom App are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this could help people track ovulation and luteal phase more accurately using fewer tests and more reliable app-assisted readings.
How similar studies have performed: Prior work using LH and BBT for ovulation detection has shown moderate success, while combining PDG measurement with AI-assisted strip interpretation is relatively novel and less well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ottawa, Ontario
- St. Laurent Ideal Clinic — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Rene A Leiva, MD
- Email: rleiva@bruyere.org
- Phone: 6135626262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.