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

NCT07248046 | Recruiting

• 1 other identifier: REB-2026-56
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• User Satisfaction with Fertility Tracking Methods

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

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

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

• 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.

• App Usability and Functionality Evaluation

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

• 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.

Study Arms (1)

Premom App Users

Women aged 16 to 45 already using the Premom App, who will track daily fertility signs over 3 menstrual cycles.

Other: Premom App-Assisted Fertility Tracking

Interventions

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.\*\*

Premom App Users

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead

Study Sites (1)

St. Laurent Ideal Clinic

Ottawa, Ontario, K1G 3V4, Canada

RECRUITING

Related Publications (15)

• Youngster M, Luz A, Baum M, Hourvitz R, Reuvenny S, Maman E, Hourvitz A. Artificial intelligence in the service of intrauterine insemination and timed intercourse in spontaneous cycles. Fertil Steril. 2023 Nov;120(5):1004-1012. doi: 10.1016/j.fertnstert.2023.07.008. Epub 2023 Jul 23.

  PMID: 37490977 BACKGROUND

• • Wang L, He L, Li J, Zeng D, Wen Y. T Line and C Line Detection and Ratio Reading of the Ovulation Test Strip Based on Deep Learning. In: Intelligent Data Engineering and Automated Learning - IDEAL 2021. Springer, Cham. Lecture Notes in Computer Science. 2021 Nov 23;(13113):625-636. https://www.researchgate.net/publication/356488630_T_Line_and_C_Line_Detection_and_Ratio_Reading_of_the_Ovulation_Test_Strip_Based_on_Deep_Learning

  BACKGROUND

• Potluri V, Kathiresan PS, Kandula H, Thirumalaraju P, Kanakasabapathy MK, Kota Sai Pavan S, Yarravarapu D, Soundararajan A, Baskar K, Gupta R, Gudipati N, C Petrozza J, Shafiee H. An inexpensive smartphone-based device for point-of-care ovulation testing. Lab Chip. 2018 Dec 18;19(1):59-67. doi: 10.1039/c8lc00792f.

  PMID: 30534677 BACKGROUND

• Pattnaik S, Das D, Venkatesan VA. Validation of urinary reproductive hormone measurements using a novel smartphone connected reader. Sci Rep. 2023 Jun 7;13(1):9227. doi: 10.1038/s41598-023-36539-w.

  PMID: 37286704 BACKGROUND

• Mendizabal-Ruiz G, Paredes O, Alvarez A, Acosta-Gomez F, Hernandez-Morales E, Gonzalez-Sandoval J, Mendez-Zavala C, Borrayo E, Chavez-Badiola A. Artificial Intelligence in Human Reproduction. Arch Med Res. 2024 Dec;55(8):103131. doi: 10.1016/j.arcmed.2024.103131. Epub 2024 Nov 29.

  PMID: 39615376 BACKGROUND

• Leiva RA, Bouchard TP, Abdullah SH, Ecochard R. Urinary Luteinizing Hormone Tests: Which Concentration Threshold Best Predicts Ovulation? Front Public Health. 2017 Nov 28;5:320. doi: 10.3389/fpubh.2017.00320. eCollection 2017.

  PMID: 29234665 BACKGROUND

• Leiva R, Ecochard R. 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. Semin Reprod Med. 2024 Jun;42(2):90-99. doi: 10.1055/s-0044-1791702. Epub 2024 Oct 8.

  PMID: 39379045 BACKGROUND

• Leiva R, McNamara-Kilian M, Niezgoda H, Ecochard R, Bouchard T. 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. BMJ Open. 2019 May 27;9(5):e028496. doi: 10.1136/bmjopen-2018-028496.

  PMID: 31133596 BACKGROUND

• Gibbons T, Reavey J, Georgiou EX, Becker CM. Timed intercourse for couples trying to conceive. Cochrane Database Syst Rev. 2023 Sep 15;9(9):CD011345. doi: 10.1002/14651858.CD011345.pub3.

  PMID: 37709293 BACKGROUND

• Ecochard R, Leiva R, Bouchard T, Boehringer H, Iwaz J, Plotton I. Descriptive analysis of the relationship between progesterone and basal body temperature across the menstrual cycle. Steroids. 2022 Feb;178:108964. doi: 10.1016/j.steroids.2022.108964. Epub 2022 Jan 20.

  PMID: 35065994 BACKGROUND

• Ecochard R, Leiva R, Bouchard T, Boehringer H, Direito A, Mariani A, Fehring R. Use of urinary pregnanediol 3-glucuronide to confirm ovulation. Steroids. 2013 Oct;78(10):1035-40. doi: 10.1016/j.steroids.2013.06.006. Epub 2013 Jul 4.

  PMID: 23831784 BACKGROUND

• Ecochard R, Duterque O, Leiva R, Bouchard T, Vigil P. Self-identification of the clinical fertile window and the ovulation period. Fertil Steril. 2015 May;103(5):1319-25.e3. doi: 10.1016/j.fertnstert.2015.01.031. Epub 2015 Feb 24.

  PMID: 25724738 BACKGROUND

• Duane M, Stanford JB, Porucznik CA, Vigil P. Fertility Awareness-Based Methods for Women's Health and Family Planning. Front Med (Lausanne). 2022 May 24;9:858977. doi: 10.3389/fmed.2022.858977. eCollection 2022.

  PMID: 35685421 BACKGROUND

• Bouchard TP, Fehring RJ, Schneider M. Pilot Evaluation of a New Urine Progesterone Test to Confirm Ovulation in Women Using a Fertility Monitor. Front Public Health. 2019 Jul 2;7:184. doi: 10.3389/fpubh.2019.00184. eCollection 2019.

  PMID: 31312631 BACKGROUND

• Bouchard TP. Using Quantitative Hormonal Fertility Monitors to Evaluate the Luteal Phase: Proof of Concept Case Study. Medicina (Kaunas). 2023 Jan 10;59(1):140. doi: 10.3390/medicina59010140.

  PMID: 36676764 BACKGROUND

Related Links

• • G. Maroju R, G. Choudhari S, Shaikh MK et al. Application of artificial intelligence-based strategies for promotion of family planning in India: a scoping review \[version 1; peer review: awaiting peer review\]. F1000Research 2023, 12:1447
• • Steward K, Raja A. Physiology, Ovulation And Basal Body Temperature. \[Updated 2023 Jul 17\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.

Central Study Contacts

Rene A Leiva, MD

CONTACT

6135626262; rleiva@bruyere.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-11

Locations

CA (1)