Ovulation Double Check (Proov) Verification and Usability Testing

NCT03924440 | Completed FDA Device

• 1 other identifier: 09/19/2016
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Ovulation Double Check test is a Class I, 510K exempt medical device. It is manufactured and packaged in an FDA-registered and cGMP compliant facility. This device measures the level of Pregnanediol (PdG), the major urine metabolite of progesterone, in the urine of women. PdG has been shown to increase significantly after ovulation has occurred. This test will be used in a home setting as a point-of-care device, providing couples additional information about menstrual cycling and possible fertile periods. The investigators have successfully developed prototype devices that can accurately measure PdG in urine. Now the investigators need to supply these prototype devices to end users to verify the assay is working correctly and determine if the device was designed properly in order for home users to 1) use the test properly, 2) read the test results properly, and 3) interpret the results correctly.

Conditions

Ovulation Disorder

Outcome Measures

Primary Outcomes (1)

• Number if participants with positive PDG test results

  PDG test results are recorded to determine when PDG test results were positive

  A single menstrual cycle, up to 45 days.

Study Arms (1)

PDG Test strip Users

Participants were asked to predict ovulation by monitoring changes in cervical mucus and/or tracking luteinizing hormone (LH) via home test kits. Participants were asked to self-report their peak fertility day, which was defined as the first LH surge day and/or day of peak cervical mucus (stretchy and eggwhite in consistence). Participants collected first morning urine as various times during their cycle, including, prior to, during, and after peak fertility signs were observed. Participants were provided PDG rapid response test strips and self-administered their tests and recorded their results. Test results were reported back researchers via a log sheet. Log sheets recorded testing date, day of cycle, date of peak fertility (if known), personal assessment of results (positive result vs negative result) and a place to tape the completed test strip.

Diagnostic Test: Proov (Ovulation Double Check) Test

Interventions

Proov (Ovulation Double Check) Test DIAGNOSTIC_TEST

Rapid response urine progesterone test strips, Proov (formerly named Ovulation Double Check

PDG Test strip Users

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Women only due to ovulation tracking diagnostic studied
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria were non-pregnant women residing within the United States, aged 18-34, and not currently on hormonal birth control. Importantly, women were not excluding due to average cycle length, weight (BMI), breastfeeding status, poly-cyctic ovarian syndrome (PCOS) or any other cause of infertility or lifestyle factor.

You may qualify if:

• Female (mandatory)
• Not currently pregnant or nursing (pregnancy affects PdG levels)
• Aged 18-34 (advanced age can hinder PdG levels)
• Cycle length of 26-39 days (long or short cycles have inconsistent PdG levels)
• Currently use other fertility monitoring tools (this allows us to compare Proov - Ovulation Double Check test results with other fertility tracking methods)

You may not qualify if:

• Male
• Pregnant
• Nursing

Sponsors & Collaborators

• MFB Fertility: lead

Study Officials

• Amy Beckley, PhD

  MFB Fertility

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Study Start: October 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share