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

NCT ID: NCT01219387

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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AMH Levels Inhibin B Levels IVF Patients Over 38 Years Old

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Organon

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul A Bergh, MD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Locations

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Reproductive Medicine Assoicates of New Jersey

Morristown, New Jersey, United States

Site Status

Reproductive Medicine Associates of PA at Lehigh Valley

Allentown, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RMA-00-09

Identifier Type: -

Identifier Source: org_study_id

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