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

Status unconfirmed · Not applicable

Conditions studied: Healthy, Fragile X Syndrome

In brief

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\*\*

Key facts

Study ID

NCT00334971

Run by

Massachusetts General Hospital

People needed

116

Starts

2004-09-01

Expected to finish

2018-01-01

Last updated by the study team

2013-11-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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