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

This study has been completed.
Sponsor:
Collaborators:
Organon
Merck
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219387
First received: October 8, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
AMH Levels
Inhibin B Levels
IVF Patients Over 38 Years Old

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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.

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • AMH levels as predictive of oocyte quality [ Time Frame: within 3 months ] [ Designated as safety issue: No ]
    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

  • AMH levels as predictive of embryo quality [ Time Frame: within 3 months ] [ Designated as safety issue: No ]
    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

  • AMH levels as predictive of implantation and pregnancy outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 300
Study Start Date: February 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   38 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219387

Locations
United States, New Jersey
Reproductive Medicine Assoicates of New Jersey
Morristown, New Jersey, United States, 07960
United States, Pennsylvania
Reproductive Medicine Associates of PA at Lehigh Valley
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Organon
Merck
Investigators
Principal Investigator: Paul A Bergh, MD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
Reproductive Medicine Associates of New Jersey  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219387     History of Changes
Other Study ID Numbers: RMA-00-09
Study First Received: October 8, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
AMH
inhibin B
infertility

ClinicalTrials.gov processed this record on May 19, 2013