NCT01219387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

October 8, 2010

Last Update Submit

January 22, 2013

Conditions

AMH LevelsInhibin B LevelsIVF Patients Over 38 Years Old

Keywords

AMHinhibin Binfertility

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    1 year

Eligibility Criteria

Age38 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Medicine Assoicates of New Jersey

Morristown, New Jersey, 07960, United States

Location

Reproductive Medicine Associates of PA at Lehigh Valley

Allentown, Pennsylvania, 18104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Paul A Bergh, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

February 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(2)