- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02673632
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
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
- Name: Karim L Emam, MBBCH
- Phone Number: +201001001696
- Email: kl_emam@hotmail.com
Study Contact Backup
- Name: Ahmed M Bahaa eldin, A.Professor
- Phone Number: +20 1111700556
- Email: abahaa0503@med.asu.edu.eg
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASU2016
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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