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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Elevation of AMH Resulted From Ovarian Structural Properties or Effects of Gonadotropines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01878955
• Other study ID #: AMH-123
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2013
• Last updated: February 28, 2018
• Start date: February 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Genetic:
• AMH level difference between patient with PCOS and multicystic ovaries.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Müllerian Hormone level 0.5ng/ml -14ng/ml.	difference of serum AMH levels between patients with PCO or multicystic ovaries	5 years