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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

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.

Condition or disease Intervention/treatment
Pregnancy Related Hormone Deficiency 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Pregnancy

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 and LH test strips, Proov




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033366


Locations
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United States, Colorado
MFB Fertility
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
MFB Fertility
Investigators
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Principal Investigator: Amy Beckely, PhD MFB Fertility
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Responsible Party: MFB Fertility
ClinicalTrials.gov Identifier: NCT05033366    
Other Study ID Numbers: 2021/03/29
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022

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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