Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes in Women Over 38 Years Old

January 22, 2013 updated by: Reproductive Medicine Associates of New Jersey

Evaluation of Serum Anti-Mullerian Hormone (AMH) and Inhibin B Levels as Early Predictors of a Successful IVF Cycle in Women Over 38 Years Old.

The present study is designed to evaluate the basal serum levels of anti-mullerian hormone (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy rate in women 38 years old or older that are undergoing an IVF cycle.

Study Overview

Status

Completed

Conditions

Detailed Description

Specifics aims are: a) to describe AMH and inhibin levels on day 3 previous to ART cycle; b) to analyze the association between these hormone levels and the retrieved metaphase II oocytes quantity; c) to analyze the association between these hormone levels and quality embryo score d) to analyze the association between these hormone levels and the number of gestational sacs per transferred-embryo (implantation rate); e) to analyze the association between these hormone levels and the pregnancy rate; f) to make a prediction model for pregnancy rate by using a multivariable regression analysis.

Patient participation includes signing the consent and having additional tubes of blood drawn at a regularly scheduled blood draw. This blood is used to run the study tests (AMH and inhibin levels).

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Reproductive Medicine Assoicates of New Jersey
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Reproductive Medicine Associates of PA at Lehigh Valley

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

38 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing IVF treatment who are over the age of 38 years.

Description

Inclusion Criteria:

1. Women 38 years old or older at the time of initiating treatment

Exclusion Criteria:

  1. Uterine disease: malformation, septum, submucosal myomas, endometrial polyps Advanced endometriosis with endometrioma (s)
  2. No uterus
  3. Single ovary

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
AMH levels as predictive of oocyte quality
Time Frame: within 3 months
Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and the oocyte quality as observed during the IVF cycle
within 3 months
AMH levels as predictive of embryo quality
Time Frame: within 3 months
Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and the embryo quality as observed during the IVF cycle
within 3 months
AMH levels as predictive of implantation and pregnancy outcomes
Time Frame: 1 year
Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and rates of implantation and delivery during that IVF cycle
1 year

Collaborators and Investigators

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

Sponsor

Reproductive Medicine Associates of New Jersey

Collaborators

Merck Sharp & Dohme LLC
Organon

Investigators

  • Principal Investigator: Paul A Bergh, MD, Reproductive Medicine Associates of New Jersey

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.

Helpful Links

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, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMA-00-09

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.

Clinical Trials on AMH Levels

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe