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Relationship Between Fertility Hormone Patterns and Pregnancy Rates.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05033366
Recruitment Status : Enrolling by invitation
First Posted : September 2, 2021
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
MFB Fertility

Tracking Information
First Submitted Date July 30, 2021
First Posted Date September 2, 2021
Last Update Posted Date August 30, 2022
Actual Study Start Date March 1, 2020
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2021)
self reported pregnancy [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 27, 2021)
self reported first trimester pregnancy loss [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
Official Title Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition
  • Pregnancy Related
  • Hormone Deficiency
Intervention Diagnostic Test: Proov Test
Rapid response urine PdG and LH test strips, Proov
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Proov Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 27, 2021)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2024
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05033366
Other Study ID Numbers 2021/03/29
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party MFB Fertility
Original Responsible Party Same as current
Current Study Sponsor MFB Fertility
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Amy Beckely, PhD MFB Fertility
PRS Account MFB Fertility
Verification Date August 2022