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NCT Number: NCT07248046

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fertility Artifical Intelligence Body Temperature Cervical Mucus Luteinizing Hormone (LH) Menstrual Cycle Mobile Applications Ovulation Progesterone

Age range

16 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Laurent Ideal Clinic

Ottawa, Ontario, K1G 3V4, Canada

About this study

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.**

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premom App-Assisted Fertility Tracking

Other

Participants use the Premom smartphone application (Easy Healthcare Corporation) to log daily fertility indicators - cervical mucus (CM), urinary luteinizing hormone (LH) strips, urinary pregnanediol glucuronide (PDG) strips, and basal body temperature (BBT) - over three menstrual cycles. Both participant-read and AI-interpreted app readings are compared to identify ovulation and luteal phase length. **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.**

Primary outcomes

  1. Agreement Between Marker Combinations and the Estimated Day of Ovulation (EDO)

    Time frame: 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.

  2. Luteal Phase Length Determined by Different Fertility Marker Combinations

    Time frame: 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.

Secondary outcomes

  1. User Satisfaction with Fertility Tracking Methods

    Time frame: At completion of Cycle 3 (cycle length up to 35 days).

    Participant satisfaction will be measured using the nineteen-item Participant Evaluation Survey, which examines clarity of instructions, ease of daily tracking, use of cervical mucus observations, LH and PDG tests, BBT measurements, app-based interpretation, time burden, and overall value. Each item uses a five-option Likert scale: Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree. Higher-rated responses indicate better usability, clearer instructions, lower perceived burden, and greater overall satisfaction.

  2. Agreement Between Participant and App Interpretations of LH and PDG Test Strips

    Time frame: At completion of Cycle 3 (cycle length up to 35 days).

    Concordance rate between participant visual interpretation and Premom App AI-assisted interpretation of LH and PDG test strip results, expressed as percent agreement.

  3. Testing Burden and Number of Testing Days per Cycle

    Time frame: Daily tracking Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.

    Average number of days participants perform LH and PDG testing per cycle across three cycles, recorded in the study tracking log and used to evaluate practicality of each marker combination.

  4. App Usability and Functionality Evaluation

    Time frame: At completion of Cycle 3 (cycle length up to 35 days).

    Participant feedback on functionality, photo upload reliability, and AI test interpretation accuracy of the Premom App, rated through the end-of-study usability survey.

  5. Correlation Between Cervical Mucus-Defined and Standard Fertile Window

    Time frame: Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.

    Comparison between fertile days identified by cervical mucus observations and the classic Wilcox fertile window (the 5 days before and including ovulation), expressed as percent overlap and mean day difference.

Sponsors and collaborators

Lead sponsor

Bruyère Health Research Institute.

Other

Registry information

Official study title

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

Acronym: SMOM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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