Relationship Between Fertility Hormone Patterns and Pregnancy Rates.

NCT05033366 | Enrolling By Invitation FDA Device

• 1 other identifier: 2021/03/29
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• self reported first trimester pregnancy loss

  Three months

Study Arms (1)

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

Interventions

Proov Test DIAGNOSTIC_TEST

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

Proov test strip users that record results with the Proov app

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female
• Age 18 - no limit
• Have completed one full cycle using the Proov app

You may not qualify if:

• Male
• Have not completed one full cycle using the Proov app

Sponsors & Collaborators

• MFB Fertility: lead

Study Sites (1)

MFB Fertility

Boulder, Colorado, 80301, United States

Location

Study Officials

• Amy Beckely, PhD

  MFB Fertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: September 2, 2021
• Study Start: March 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)