Relationship Between Fertility Hormone Patterns and Pregnancy Rates.

• Conditions: Hormone Deficiency; Pregnancy Related
• Interventions: Diagnostic Test: Proov Test

• Registration Number: NCT05033366
• Lead Sponsor: MFB Fertility

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proov test strip users that record results with the Proov app	Proov Test	Participants using Proov test strips along with the Proov app who have logged at least one complete cycle will be asked to complete an online survey about fertility test results and current/previous pregnancy status. They will also be asked cycle history (irregular vs regular, cycle length), fertility testing (partners semen analysis results, AMH level, HSG results), possible fertility medications taken or prescribed, age, race, smoking status, and BMI.

Primary Outcome Measures

Name	Time	Method
self reported pregnancy	Two menstrual cycle, up to 45 days each	Questionnaire used to assess if positive Proov test strips measuring urine PDG correlate with increased rates of self reported pregnancy

Secondary Outcome Measures

Name	Time	Method
self reported first trimester pregnancy loss	Three months	Questionnaire used to assess if negative Proov test strips measuring urine PDG correlate with increased rates of self reported first trimester pregnancy loss

Trial Locations

Locations (1)

MFB Fertility; 🇺🇸 Boulder, Colorado, United States