Clinical Trial: Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Aromatase Activity and Ovarian Growth Factors in Preovulatory Follicles

Brief Summary:

The purpose of the study is to understand how the ovarian follicle (the fluid filled structure in the ovary that contains the egg) makes estrogen and other hormones during normal aging, in women with different ethnic backgrounds, and in Fragile X premutation carriers.

During reproductive aging, estradiol levels are increased, a phenomenon that may be related to increased aromatase activity. The investigators' own preliminary data suggest that estradiol is increased in African-American women compared to Caucasian women, which may also be related to aromatase activity. In addition, the investigators have examined female fragile X premutation carriers who still have regular menstrual cycles and have demonstrated evidence of early ovarian aging compared to age-matched controls.

**WE ARE RECRUITING ONLY WOMEN WITH FRAGILE-X PREMUTATION**


Detailed Summary:

The purpose of the study is to examine intrafollicular changes in aromatase and ovarian growth factors in reproductive aged women,African-American women compared to Caucasian controls, and Fragile X premutation carriers.

Hypotheses:

  • Aromatase activity is up-regulated in preovulatory follicles with aging, accounting for the increased estradiol levels in the face of decreased inhibin secretion in reproductive aging.
  • Increased estradiol in the face of normal inhibin A and inhibin B suggests up-regulation of aromatase in African-American women.
  • Aromatase activity is down-regulated in preovulatory follicles in fragile X premutation carriers compared to age-matched controls and the activity is associated with FMR1 mRNA levels.

Sponsor: Massachusetts General Hospital

Current Primary Outcome:

  • Serum androstenedione, E2, A/E2, inhibin A, and inhibin B [ Time Frame: at first day of menses until day after aspiration procedure ]
  • Follicular fluid androstenedione, E2, A/E2, inhibin A, and inhibin B [ Time Frame: after aspiration procedure ]
  • RT-PCR results for aromatase in aspirated follicular fluid, when follicle is > 14 mm [ Time Frame: after aspiration procedure ]


Original Primary Outcome:

  • Serum androstenedione, E2, A/ E2, inhibin A, and inhibin B, at first day of menses until day after aspiration procedure
  • Follicular fluid androstenedione, E2, A/ E2, inhibin A, and inhibin B, at first day of menses until day after aspiration procedure
  • RT-PCR results for aromatase in aspirated follicular fluid, when follicle is > 14 mm


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: June 7, 2006
Date Started: September 2004
Date Completion: January 2018
Last Updated: November 5, 2013
Last Verified: November 2013