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FertilitySMOMNCT07248046

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

An observational study of Fertility and Mobile Applications, run by Bruyère Health Research Institute. at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Premom App-Assisted Fertility Tracking
How many people
30 participants
Where
1 siteCanada
Study dates
15 Jan 2026to 15 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Laurent Ideal Clinic

    Ottawa, Ontario, K1G 3V4

Other trials in Canada

About this study

Official 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

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.

Read the 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.

Being tested
Premom App-Assisted Fertility Tracking
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Premom App-Assisted Fertility TrackingOther

    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.

Study groups in NCT07248046
Study groupRoleWhat they receive
Premom App UsersWomen aged 16 to 45 already using the Premom App, who will track daily fertility signs over 3 menstrual cycles.
Receives: Other: Premom App-Assisted Fertility Tracking

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start15 Jan 2026
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07248046
Sponsor's protocol ID
REB-2026-56
Acronym
SMOM
Status last verified
Jul 2026
First submitted
14 Nov 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37490977

  • • 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

  • 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.

    PubMed 30534677

  • 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.

    PubMed 37286704

  • 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.

    PubMed 39615376

  • 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.

    PubMed 29234665

  • 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.

    PubMed 39379045

  • 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.

    PubMed 31133596

  • 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.

    PubMed 37709293

  • 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.

    PubMed 35065994

  • 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.

    PubMed 23831784

  • 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.

    PubMed 25724738

  • 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.

    PubMed 35685421

  • 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.

    PubMed 31312631

  • 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.

    PubMed 36676764

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility and Mobile Applications, run by Bruyère Health Research Institute. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07248046, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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