Anti-Mullerian HormoneNCT03131388
Clinical Performance Evaluation of AMH Assay
An observational study of Anti-Mullerian Hormone, run by Beckman Coulter, Inc. at 13 sites in 2 countries.
Trial summary
The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Anti-Mullerian Hormone
- What is being tested?
- Access AMH Assay
- How many people
- 277 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2016to 30 Apr 2018
- 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 21 to 45 years
- Women only
- Adult
Study population: Adult women presenting to fertility clinics for fertility assessment
Who may be able to join
- ≥ 21 and < 46 years of age
- Regular menstrual cycle
- Both ovaries present
Who cannot join
- Evidence of PCOS
- Confirmed ovarian endometrioma
- Ovarian surgery prior to enrollment
- Being treated for cancer
- Hormonal contraceptive use prior to enrollment
- Currently pregnant
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Mainline Fertility
Bryn Mawr, Pennsylvania, 19010
WRMG
Clearwater, Florida, 33759
CARE
Dallas, Texas, 76022
RAD
Newark, Delaware, 19713
Stanford
Palo Alto, California, 94305
Univ Pennsylvania
Philadelphia, Pennsylvania, 19104
BRI
Phoenix, Arizona, 85258
FSMG
San Diego, California, 92123
PNWF
Seattle, Washington, 98104
Vios Fertility
Swansea, Illinois, 62226
BIVF
Waltham, Massachusetts, 02451
CORM
Webster, Texas, 77598
About this study
The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.
Read the detailed description
same as brief summary
- Conditions
- Anti-Mullerian Hormone
- Being tested
- Access AMH Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access AMH AssayDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of AMH as an aid for fertility assessment
Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve
Measured: Day 2 to 4 of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startSep 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Mullerian HormoneStudies 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
- Cross-sectional
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Siebert, Study director, Beckman Coulter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131388
- Sponsor's protocol ID
- AMH 2.7.1
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of AMH Assay
- ClinicalTrials.gov ID
- NCT03131388
- Acronym / sponsor ID
- AMH 2.7.1
- Conditions
- Anti-Mullerian Hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 27 Apr 2017 (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 Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.
Detailed description
same as brief summary
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Adult women presenting to fertility clinics for fertility assessment
Key inclusion criteria (3 listed)
- ≥ 21 and < 46 years of age
- Regular menstrual cycle
- Both ovaries present
Key exclusion criteria (6 listed)
- Evidence of PCOS
- Confirmed ovarian endometrioma
- Ovarian surgery prior to enrollment
- Being treated for cancer
- Hormonal contraceptive use prior to enrollment
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 |
|---|---|---|
| Access AMH Assay | Diagnostic test | – |
Primary outcome
Measurement of AMH as an aid for fertility assessment
Time frame: Day 2 to 4 of menstrual cycle
Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve
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 13 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Fred Siebert study director
Beckman Coulter
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-Mullerian Hormone, run by Beckman Coulter, Inc. at 13 sites in 2 countries.
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 6 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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?
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?
Measurement of AMH as an aid for fertility assessment (time frame: Day 2 to 4 of menstrual cycle). 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 13 Jul 2018.