Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM … (NCT07248046) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM Study)
Canada30 participantsStarted 2026-01-15
Plain-language summary
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.
Who can participate
Age range
16 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement Between Marker Combinations and the Estimated Day of Ovulation (EDO)
Timeframe: Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant
2
Luteal Phase Length Determined by Different Fertility Marker Combinations
Timeframe: Daily tracking through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.