The Influence of AMH on Ovarian Responsiveness to Ovulation Induction With GnRH in Women With PCOS

February 3, 2016 updated by: Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

The Influence of Anti-Müllerian Hormone on Ovarian Responsiveness to Ovulation Induction With Gonadotrophins in Women With Polycystic Ovarian Syndrome

The investigator suggests that PCOS women with high AMH levels are resistant to ovarian stimulation and may need adjustment of the dose of gonadotrophin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is a correlation between high levels of AMH and the severity of PCOS. Excessive AMH may have a negative effect on the sensitivity of the resting follicles to gonadotropins.

This is an observational prospective study to investigate the impact of circulating AMH on gonadotrophin induction in women with PCOS.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population comprises women with PCOS, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, assisted reproductive technology (ART) Unit, during the study period, who are planning for Intracytoplasmic sperm injection (ICSI).

Description

Inclusion Criteria:

  • Women of age 18 - 35 years
  • BMI 20 - 30 kg/m2
  • Anovulatory infertility
  • Diagnosis of PCOS based on Rotterdam consensus criteria (two of three criteria: Oligo/anovulation, hyperandrogenaemia and sonographic appearance of polycystic ovaries)

Exclusion Criteria:

  • Women Above 35 years or under 18 years
  • Women with BMI above 30 kg/m2 or under 20 kg/m2
  • Normally ovulating women
  • Patients with marked hyperandrogenaemia were screened for congenital adrenal hyperplasia (by measuring serum concentration of 17alpha hydroxyl-progesterone) or Patients with Cushing syndrome (by measuring urinary free cortisol)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment.
Time Frame: 30 days
Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment.
30 days

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

May 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

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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