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NCT Number: NCT01219387

Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes 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.

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Key information

Conditions

AMH Levels Genital Diseases IVF Patients Over 38 Years Old Infertility Inhibin B Levels Urogenital Diseases

Age range

38 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Assoicates of New Jersey, Morristown, New Jersey, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Organon

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 13, 2010
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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