Status:
UNKNOWN
Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Healthy
Fragile X Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 ...
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 p...
Eligibility Criteria
Inclusion
- 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
- Hemoglobin level less than 11 gm/dl at time of screening
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00334971
Start Date
September 1 2004
End Date
January 1 2018
Last Update
November 6 2013
Active Locations (1)
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1
Reproductive Endocrine Unit, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114