Artifical Intelligence, Body Temperature, Cervical Mucus, Fertility, Luteinizing Hormone (LH), Menstrual Cycle, Mobile Applications, Ovulation, Progesterone
Conditions
Keywords
Ovulation, Luteal Phase, Menstrual Cycle, Fertility, Cervical Mucus, Luteinizing Hormone, Pregnanediol Glucuronide, Progesterone, Basal Body Temperature, Female Reproductive Physiology, Fertility Awareness-Based Methods, Mobile Applications, Smartphone App, Artificial Intelligence, Self-Testing, Home Diagnostic Tests, Observational Study, Prospective Studies, Digital Health, Women's Health
Brief 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.
Detailed description
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.\*\*
Interventions
OTHERPremom App-Assisted Fertility Tracking
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.\*\*
Sponsors
Bruyère Health Research Institute.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Marker Combinations and the Estimated Day of Ovulation (EDO) | 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. |
| Luteal Phase Length Determined by Different Fertility Marker Combinations | 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
| Measure | Time frame | Description |
|---|---|---|
| User Satisfaction with Fertility Tracking Methods | 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. |
| Agreement Between Participant and App Interpretations of LH and PDG Test Strips | 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. |
| Testing Burden and Number of Testing Days per Cycle | 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. |
| App Usability and Functionality Evaluation | 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. |
| Correlation Between Cervical Mucus-Defined and Standard Fertile Window | 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. |
Countries
Canada
Outcome results
None listed