The Use Of AMH for the Discrimination of Polycystic and Multicystic Ovaries in Nonhyperandrogenic Patients

February 28, 2018 updated by: Serpil aydoğmuş, Izmir Katip Celebi University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • Between the ages of 15-43
  • >6 4-9 mm follicles in bilateral ovaries at ultrasonographic examination
  • Increased ovarian volume (>10 ml )

Exclusion Criteria:

  • Hormonal drug users
  • Late onset congenital adrenal hyperplasia,androgen secreted ovarian or adrenal tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
->6 4-9 mm follicles in bilateral ovaries
Between the ages of 18-35 patients diagnosed with PCOS according to the Roterdam criteria
Genetic: AMH level difference between patient with PCOS and multicystic ovaries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Study Director: Serpil Aydoğmuş, assoc prof, Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMH-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

only results

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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