Ovulation DisorderNCT03924440
Ovulation Double Check (Proov) Verification and Usability Testing
An observational study of Ovulation Disorder, run by MFB Fertility.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Ovulation Disorder
- What is being tested?
- Proov (Ovulation Double Check) Test
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 31 Dec 2022
- 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 to 34 years
- Women only
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- Male
- Pregnant
- Nursing
About this study
Official title: Characterization and Use of Urine Pregnanediol Rapid Test and Its Use for Confirming Ovulation - Proov (Ovulation Double Check) Test
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.
Read the detailed description
Lack of or insufficient ovulatory events is the primary cause of infertility worldwide and with 12% of couples within the US being diagnosed with infertility each year (according to the CDC), thus being able to confirm ovulation is an essential component of infertility evaluations in women. The gold standards for confirming ovulation include transvaginal ultrasounds and serum progesterone blood draws. Both of these techniques are too invasive, too expensive, and/or inaccessible to most women. Therefore a non-invasive, inexpensive, home-based testing system to confirm ovulation is desired. Several recent studies have identified urinary pregnanediol levels as an accurate way to confirm ovulation. However, until now, urine pregnanediol levels were always measured via a lab setting. Here the investigators describe the development of a urine pregnanediol (PDG) rapid test and its use at confirming ovulation in a home environment. Study Protocol One hundred and ninety six women were recruited to take part in a prospective, blinded cohort home environment study. The study protocol was approved by the Ethics Committee at Solutions IRB. Detailed information about the study was provided to each volunteer, and informed consent was obtained prior the study commencement. Inclusion criteria were non-pregnant women residing within the United States, aged 18- 45, 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. 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 the tests and recorded the results. Test results were reported back the investigators 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.
- Conditions
- Ovulation Disorder
- Being tested
- Proov (Ovulation Double Check) Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proov (Ovulation Double Check) TestDiagnostic test
Rapid response urine progesterone test strips, Proov (formerly named Ovulation Double Check
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Proov (Ovulation Double Check) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number if participants with positive PDG test results
PDG test results are recorded to determine when PDG test results were positive
Measured: A single menstrual cycle, up to 45 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Oct 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation DisorderStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MFB Fertility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Beckley, PhD, Principal investigator, MFB Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924440
- Sponsor's protocol ID
- 09/19/2016
- Status last verified
- Mar 2024
- First submitted
- 17 Apr 2019
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Characterization and Use of Urine Pregnanediol Rapid Test and Its Use for Confirming Ovulation - Proov (Ovulation Double Check) Test
- ClinicalTrials.gov ID
- NCT03924440
- Acronym / sponsor ID
- 09/19/2016
- Conditions
- Ovulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MFB FertilityIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Apr 2019 (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 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.
Detailed description
Lack of or insufficient ovulatory events is the primary cause of infertility worldwide and with 12% of couples within the US being diagnosed with infertility each year (according to the CDC), thus being able to confirm ovulation is an essential component of infertility evaluations in women. The gold standards for confirming ovulation include transvaginal ultrasounds and serum progesterone blood draws. Both of these techniques are too invasive, too expensive, and/or inaccessible to most women. Therefore a non-invasive, inexpensive, home-based testing system to confirm ovulation is desired. Several recent studies have identified urinary pregnanediol levels as an accurate way to confirm ovulation. However, until now, urine pregnanediol levels were always measured via a lab setting. Here the investigators describe the development of a urine pregnanediol (PDG) rapid test and its use at confirming ovulation in a home environment. Study Protocol One hundred and ninety six women were recruited to take part in a prospective, blinded cohort home environment study. The study protocol was approved by the Ethics Committee at Solutions IRB. Detailed information about the study was provided to each volunteer, and informed consent was obtained prior the study commencement. Inclusion criteria were non-pregnant women residing within the United States, aged 18- 45, 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. 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 the tests and recorded the results. Test results were reported back the investigators 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDG Test strip Users | – | Diagnostic Test: Proov (Ovulation Double Check) TestParticipants 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Male
- Pregnant
- Nursing
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 (Ovulation Double Check) TestRapid response urine progesterone test strips, Proov (formerly named Ovulation Double Check | Diagnostic test | PDG Test strip Users |
Primary outcome
Number if participants with positive PDG test results
Time frame: A single menstrual cycle, up to 45 days.
PDG test results are recorded to determine when PDG test results were positive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Ovulation Disorder
Recruiting
LE + CC vs. LE for Ovulation Induction
Letrozole, Clomiphene Citrate
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
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 Beckley, PhD principal investigator
MFB Fertility
Questions about this trial
What is this clinical trial studying?
An observational study of Ovulation Disorder, run by MFB Fertility.
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 5 inclusion and 3 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: finished, 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number if participants with positive PDG test results (time frame: A single menstrual cycle, up to 45 days.). 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.