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 : September 2, 2021
|Condition or disease||Intervention/treatment|
|Pregnancy Related Hormone Deficiency||Diagnostic Test: Proov Test|
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]|
|Estimated Enrollment :||5000 participants|
|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 2022|
|Estimated Study Completion Date :||April 2022|
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
- 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
- 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
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
|United States, Colorado|
|Boulder, Colorado, United States, 80301|
|Principal Investigator:||Amy Beckely, PhD||MFB Fertility|