Polycystic Ovary SyndromeNCT01878955
The Use Of AMH for the Discrimination of Polycystic and Multicystic Ovaries in Nonhyperandrogenic Patients
An observational study of Polycystic Ovary Syndrome, run by Izmir Katip Celebi University.
Trial summary
AMH is a member of the transforming growth factor family. It is produced by the granulosa cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the antimüllerian hormone. Read more about this study
- Who is it for?
- Ages 15 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- AMH level difference between patient with PCOS and multicystic ovaries.
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 31 Dec 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 15 to 43 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: primary care clinic
Who may be able to join
- Between the ages of 15-43
- >6 4-9 mm follicles in bilateral ovaries at ultrasonographic examination
- Increased ovarian volume (>10 ml )
Who cannot join
- Hormonal drug users
- Late onset congenital adrenal hyperplasia,androgen secreted ovarian or adrenal tumors
About this study
Official title: Elevation of AMH Resulted From Ovarian Structural Properties or Effects of Gonadotropines
AMH is a member of the transforming growth factor family. It is produced by the granulosa cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the antimüllerian hormone. AMH production continues until response to exogenous FSH occurs and follicles reach 4-6 mm in diameter.The number of follicles in patients with polycystic ovaries are 2-6 times higher than normal women. Serum AMH levels are 2-3 times higher in patients with PCOS. The cause of elevated serum AMH levels in patients with PCOS is unknown. There are data showing elevated serum AMH level is due to the increase in the number of follicles 2-8 mm in diameter. Although there is no precise definition; multicystic ovarian is defined by the presence of more than six follicles 4-9 mm in diameter and mixed morphologically with PCO. PCO and multicystic ovaries are distinguished by the absence of the increase in stroma / volume.The aim of this study is to investigate whether there is a difference of serum AMH levels between patients with PCO or multicystic ovaries. A primary goal is to investigate the usability of AMH as a marker besides ultrasound for discrimination of nonhyperandrogenic patients with PCO or multicystic ovaries.
Read the detailed description
It is planned to compare the values of FSH/LH, AMH, and 75 gr OGTT between 20 patients diagnosed as PCOS according to the AES-Rotterdam criteria and 20 patients with multicystic ovarian structure but do not provide the PCOS-D3 criteria. The second purpose of this study is to investigate the mechanism that leads to the elevation of AMH in patients with PCOS, and to reveal the effects of intraovarian paracrine factors,insulin resistance and FSH /LH.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- AMH level difference between patient with PCOS and multicystic ovaries.
- Keywords
- Antimullarian hormone(AMH), Polycystic Ovary, Multicystic Ovary
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMH level difference between patient with PCOS and multicystic ovaries.Genetic
| Study group | Role | What they receive |
|---|---|---|
| ->6 4-9 mm follicles in bilateral ovaries | Between the ages of 18-35 patients diagnosed with PCOS according to the Roterdam criteria Receives: Genetic: AMH level difference between patient with PCOS and multicystic ovaries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Müllerian Hormone level 0.5ng/ml -14ng/ml.
difference of serum AMH levels between patients with PCO or multicystic ovaries
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startFeb 2016
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil aydoğmuş, Izmir Katip Celebi University
- Investigators
- Serpil Aydoğmuş, assoc prof, Study director, Izmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878955
- Sponsor's protocol ID
- AMH-123
- Status last verified
- Feb 2018
- First submitted
- 14 May 2013
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: only results
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevation of AMH Resulted From Ovarian Structural Properties or Effects of Gonadotropines
- ClinicalTrials.gov ID
- NCT01878955
- Acronym / sponsor ID
- AMH-123
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Antimullarian hormone(AMH), Polycystic Ovary, Multicystic Ovary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 17 Jun 2013 (estimated)
- 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.
AMH is a member of the transforming growth factor family. It is produced by the granulosa cells from 36th weeks of pregnancy.Ovarian granulosa cells are the only source of the antimüllerian hormone. AMH production continues until response to exogenous FSH occurs and follicles reach 4-6 mm in diameter.The number of follicles in patients with polycystic ovaries are 2-6 times higher than normal women. Serum AMH levels are 2-3 times higher in patients with PCOS. The cause of elevated serum AMH levels in patients with PCOS is unknown. There are data showing elevated serum AMH level is due to the increase in the number of follicles 2-8 mm in diameter. Although there is no precise definition; multicystic ovarian is defined by the presence of more than six follicles 4-9 mm in diameter and mixed morphologically with PCO. PCO and multicystic ovaries are distinguished by the absence of the increase in stroma / volume.The aim of this study is to investigate whether there is a difference of serum AMH levels between patients with PCO or multicystic ovaries. A primary goal is to investigate the usability of AMH as a marker besides ultrasound for discrimination of nonhyperandrogenic patients with PCO or multicystic ovaries.
Detailed description
It is planned to compare the values of FSH/LH, AMH, and 75 gr OGTT between 20 patients diagnosed as PCOS according to the AES-Rotterdam criteria and 20 patients with multicystic ovarian structure but do not provide the PCOS-D3 criteria. The second purpose of this study is to investigate the mechanism that leads to the elevation of AMH in patients with PCOS, and to reveal the effects of intraovarian paracrine factors,insulin resistance and FSH /LH.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ->6 4-9 mm follicles in bilateral ovaries | – | Genetic: AMH level difference between patient with PCOS and multicystic ovaries.Between the ages of 18-35 patients diagnosed with PCOS according to the Roterdam criteria |
Who may qualify
- Ages
- 15 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- Between the ages of 15-43
- >6 4-9 mm follicles in bilateral ovaries at ultrasonographic examination
- Increased ovarian volume (>10 ml )
Key exclusion criteria (2 listed)
- Hormonal drug users
- Late onset congenital adrenal hyperplasia,androgen secreted ovarian or adrenal tumors
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 |
|---|---|---|
| AMH level difference between patient with PCOS and multicystic ovaries. | Genetic | ->6 4-9 mm follicles in bilateral ovaries |
Primary outcome
Anti-Müllerian Hormone level 0.5ng/ml -14ng/ml.
Time frame: 5 years
difference of serum AMH levels between patients with PCO or multicystic ovaries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Undecided. only results
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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.
Serpil Aydoğmuş, assoc prof study director
Izmir Katip Çelebi University
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Izmir Katip Celebi University.
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 1 Mar 2018. 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?
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?
Anti-Müllerian Hormone level 0.5ng/ml -14ng/ml. (time frame: 5 years). 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 1 Mar 2018.