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

November 5, 2013 updated by: Janet E. Hall, MD, Massachusetts General Hospital

Aromatase Activity and Ovarian Growth Factors in Preovulatory Follicles

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**

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Reproductive Endocrine Unit, Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Reproductively Younger Non-African-American Women:

  • 18-35 years of age
  • Body mass index (BMI) less than or equal to 30
  • Regular menstrual cycles (25-35 days long)
  • Negative beta-human chorionic gonadotrophin (HCG)
  • Normal prolactin and thyroid stimulating hormone (TSH) levels
  • Hemoglobin greater than or equal to 11.0 gm/dl
  • Luteal phase progesterone level indicating ovulation on a previous cycle (> 3 ng/ml)
  • Not currently trying to get pregnant
  • No blood donations within 2 months of initiating the blood sampling portion of the study
  • On no medications thought to interfere with normal menstrual cycle dynamics
  • Not current smokers or no exposure to passive smoke in the home or workplace (greater than 8 hours per day with a smoker of > 10 cigarettes per day)
  • Normal platelet count and PT/PTT
  • No history of pelvic adhesions and accessible ovarian position as assessed by transvaginal ultrasound

Reproductively Younger African-American Women:

  • 18-35 years of age
  • Meets all other inclusion criteria for the reproductively younger non-African-American population outlined above

Reproductively Older Non-African-American Women:

  • 36-45 years of age
  • Meets all other inclusion criteria for the reproductively younger non-African-American population outlined above.

Reproductive Aged Fragile X Premutation Carriers

  • Fragile X premutation carriers, with FMR1 CGG repeat lengths between 41 and 200.
  • 18-45 years of age
  • Meets all other inclusion criteria for the reproductively younger non-African-American population outlined above.

Exclusion Criteria:

  • Hemoglobin level less than 11 gm/dl at time of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Healthy Caucasian women 18-35 years old
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
Other: 2
Healthy African-American women 18-35 years old
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
Other: 3
Healthy Caucasian women 36-45 years old
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.
Other: 4
Female fragile X premutation carriers 18-45 years old
Procedure: Follicle Aspiration
Follicles will be aspirated using a transvaginal ultrasound guided needle.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

January 1, 2012

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002-P-001354
  • Sundry (Other Identifier: MGH-REU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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