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

N/ACompletedNCT01219387

Reproductive Medicine Associates of New Jersey300 enrolled

Overview

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.

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

300

Conditions

AMH Levels Inhibin B Levels IVF Patients Over 38 Years Old

Eligibility

Sex: FEMALEMin age: 38 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Reproductive Medicine Assoicates of New Jersey

Morristown, New Jersey, United States

Reproductive Medicine Associates of PA at Lehigh Valley

Allentown, Pennsylvania, United States

Outcomes

Primary Outcomes

AMH levels as predictive of oocyte quality

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

Time frame: within 3 months

AMH levels as predictive of embryo quality

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

Time frame: within 3 months

AMH levels as predictive of implantation and pregnancy outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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