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

Completed

• Conditions: IVF Patients Over 38 Years Old; AMH Levels; Inhibin B Levels

• Registration Number: NCT01219387
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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

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 Timeline

• Study Start: 2006-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMH levels as predictive of oocyte quality	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
AMH levels as predictive of embryo quality	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
AMH levels as predictive of implantation and pregnancy outcomes	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

Trial Locations

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