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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05033366
Other study ID # 2021/03/29
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date April 2026

Study information

Verified date March 2024
Source MFB Fertility
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine if certain patterns of hormone levels during the menstrual cycle are correlated with different pregnancy outcomes.


Description:

Proov tests are fertility tracking tests. They are used for monitoring ovulation at home, and are able to measure one or more hormones. These hormones can predict and confirm ovulation. Tracking these hormones can help a woman understand if she is ovulating, and can help to identify problems that could be preventing pregnancy. After giving permission to access your testing history collected in the Proov app from March 2020 to April 2022, you will complete an online survey about your fertility test results and pregnancy status. You will also be asked information regarding your age, race, smoking status, and BMI. Your test results logged in the Proov app will be shared automatically. You will need 10-20 minutes to fill out the fertility survey.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 5000
Est. completion date April 2026
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female 2. Age 18 - no limit 3. Have completed one full cycle using the Proov app Exclusion Criteria: 1. Male 2. Have not completed one full cycle using the Proov app

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Proov Test
Rapid response urine PdG, FSH, E1G and LH test strips, Proov

Locations

Country Name City State
United States MFB Fertility Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
MFB Fertility

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary self reported pregnancy Questionnaire used to assess if positive Proov test strips measuring urine PDG correlate with increased rates of self reported pregnancy Two menstrual cycle, up to 45 days each
Secondary self reported first trimester pregnancy loss Questionnaire used to assess if negative Proov test strips measuring urine PDG correlate with increased rates of self reported first trimester pregnancy loss Three months
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