Relationship Between Fertility Hormone Patterns and Pregnancy Rates.

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy Related; Hormone Deficiency
• Intervention / Treatment: Diagnostic test: Proov Test

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • MFB Fertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Females age 18 - no limit who are using, or have used, the Proov hormone test strips and the Proov app for at least one full cycle.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Proov test strip users that record results with the Proov app; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MFB Fertility
• Investigators: Principal Investigator: Amy Beckely, PhD, MFB Fertility

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021/03/29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only cohort data will be released

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes