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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16-45
SponsorBruyère Health Research Institute.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant or breastfeeding

Current hormonal therapy or contraception

Known anovulatory disorders, e.g., Polycystic Ovary Syndrome, hypothalamic amenorrhea.

Very irregular or absent cycles

Trial population

This study will include up to 30 adult women aged 16 to 45 years who have natural menstrual cycles and are current users of the Premom smartphone application for fertility tracking. All participants will reside within approximately 50 kilometers of Ottawa, Ontario, Canada. Participants must be off hormonal contraception for at least three months and willing to record daily fertility signs-cervical mucus, urinary LH and PDG test results, and basal body temperature-over three consecutive menstrual cycles. The study population represents healthy women of reproductive age who are already engaged in self-tracking of fertility and menstrual health using mobile technology.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Premom App-Assisted Fertility Tracking

    Other intervention

    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.\*\*

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Premom App Users1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
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

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.

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

Secondary outcomes

1

User Satisfaction with Fertility Tracking Methods

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.

Time frame
At completion of Cycle 3 (cycle length up to 35 days).
2

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

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

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

Testing Burden and Number of Testing Days per Cycle

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.

Time frame
Daily tracking Through completion of each menstrual cycle (cycle length up to 35 days), over 3 consecutive cycles per participant.
4

App Usability and Functionality Evaluation

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

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

Other outcomes

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