Actively Recruiting

Age: 16Years - 45Years
FEMALE
Healthy Volunteers
ID07248046

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

Led by Bruyère Health Research Institute. · Updated on 2026-01-13

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying different combinations of fertility signs to find the most reliable ways to identify ovulation and the length of the luteal phase in women. This observational study focuses on cervical mucus, urinary hormone levels (luteinizing hormone and pregnanediol glucuronide), and basal body temperature. The goal is to compare how well these markers work together in tracking fertility and to understand which pairs give the most accurate results using data collected through the Premom smartphone app. Participants who are current users of the Premom App will record daily fertility signs over three menstrual cycles. They will track cervical mucus, perform urine tests for hormone levels, take photos of test strips to upload to the app, and measure basal body temperature. Both participant-read and AI-assisted app readings will be analyzed to compare the accuracy of different marker combinations: mucus plus PDG, LH plus PDG, mucus plus BBT, and LH plus BBT. During the study, participants will log their observations daily for up to three cycles, each lasting up to 35 days. Researchers will assess agreement between marker combinations and the estimated day of ovulation, luteal phase length, user satisfaction, test burden, and app usability. The study also evaluates how well the app interpretations match participant readings. Participation involves regular tracking and data entry with minimal risk, and the study runs until November 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility and consent

Monitoring

Duration - Up to 3 menstrual cycles, each up to 35 days

Participants use the Premom smartphone app to daily track fertility signs including cervical mucus, urinary hormone test strips (LH and PDG), and basal body temperature over three menstrual cycles.

Daily self-tracking through completed cycles

Long-term Monitoring

Duration - Through completion of all 3 cycles, up to approximately 105 days

Data collected during tracking is analyzed to compare fertility marker combinations and evaluate usability and participant-app agreement.

1 visit at completion of tracking for feedback and evaluation

Trial Site Locations

Total: 1 location

1

St. Laurent Ideal Clinic

Ottawa, Ontario, Canada, K1G 3V4

Actively Recruiting

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Research Team

R

Rene A Leiva, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Helping Patients to Predict and Confirm Ovulation with the Use of Combined Urinary Hormonal and Smartphone Technology: A Proof-of-Concept Retrospective Descriptive Case Series.

Rene Leiva, Rene Ecochard

https://pubmed.ncbi.nlm.nih.gov/39379045

Pilot observational prospective cohort study on the use of a novel home-based urinary pregnanediol 3-glucuronide (PDG) test to confirm ovulation when used as adjunct to fertility awareness methods (FAMs) stage 1.

Rene Leiva, Marie McNamara-Kilian, Helen Niezgoda...

https://pubmed.ncbi.nlm.nih.gov/31133596

Descriptive analysis of the relationship between progesterone and basal body temperature across the menstrual cycle.

René Écochard, René Leiva, Thomas Bouchard...

https://pubmed.ncbi.nlm.nih.gov/35065994