Pregnancy RelatedNCT05033366
Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
An observational study of Pregnancy Related and Hormone Deficiency, run by MFB Fertility at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Hormone Deficiency
- What is being tested?
- Proov Test
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to Apr 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Female
- Age 18 - no limit
- Have completed one full cycle using the Proov app
Who cannot join
- Male
- Have not completed one full cycle using the Proov app
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if certain patterns of hormone levels during the menstrual cycle are correlated with different pregnancy outcomes.
Read the 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.
- Conditions
- Pregnancy Related, Hormone Deficiency
- Being tested
- Proov Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proov TestDiagnostic test
Rapid response urine PdG, FSH, E1G and LH test strips, Proov
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Proov Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
self reported pregnancy
Questionnaire used to assess if positive Proov test strips measuring urine PDG correlate with increased rates of self reported pregnancy
Measured: Two menstrual cycle, up to 45 days each
Secondary outcomes (1)
self reported first trimester pregnancy loss
Questionnaire used to assess if negative Proov test strips measuring urine PDG correlate with increased rates of self reported first trimester pregnancy loss
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Mar 2020
- Primary completionApr 2024 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- MFB Fertility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Beckely, PhD, Principal investigator, MFB Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033366
- Sponsor's protocol ID
- 2021/03/29
- Status last verified
- Mar 2024
- First submitted
- 30 Jul 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: only cohort data will be released
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
- ClinicalTrials.gov ID
- NCT05033366
- Acronym / sponsor ID
- 2021/03/29
- Conditions
- Pregnancy Related, Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- MFB FertilityIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proov test strip users that record results with the Proov app | – | Diagnostic Test: Proov TestParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female
- Age 18 - no limit
- Have completed one full cycle using the Proov app
Key exclusion criteria (2 listed)
- Male
- Have not completed one full cycle using the Proov app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proov TestRapid response urine PdG, FSH, E1G and LH test strips, Proov | Diagnostic test | Proov test strip users that record results with the Proov app |
Primary outcome
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
1 secondary outcome
self reported first trimester pregnancy loss
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No. only cohort data will be released
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Beckely, PhD principal investigator
MFB Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Hormone Deficiency, run by MFB Fertility at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self reported pregnancy (time frame: Two menstrual cycle, up to 45 days each). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.