Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00006156
Eligibility Criteria:
* INCLUSION CRITERIA:
A. Women with normal ovarian function:
Age 18 to 55.
Normal body mass index (18-30 kg/m(2)).
Normal menstrual cycles (between 25-35 days in length).
Ovulatory serum progesterone concentrations (in excess of 6 ng/mL in the menstrual cycle just preceding the study cycle).
B. Postmenopausal women (to serve as negative controls):
Greater than or equal to 60 years of age.
Proven fertility (as evidenced by a history of pregnancy regardless of outcome).
Normal body mass index (18-30 kg/m(2)).
Naturally menopausal: amenorrhea for at least one year; serum FSH greater than 40 IU/mL.
C. Women carriers of FMR1 premutations:
Age 18 to 40.
50 to 200 CGG repeats.
Normal menstrual cycles (between 25-35 days in length).
Have previously had genetic counseling regarding their FMR1 status.
EXCLUSION CRITERIA:
History of infertility or infertility in a first degree relative.
Acute or chronic disease.
Menopause due to surgery, radiation, or chemotherapy.
Current use of oral contraceptives or hormone replacement therapy, or use of these agents within the previous 3 months.
Use within the previous three months of any medication known to affect the hypothalamic-pituitary-ovarian axis (including over-the-counter and alternative medicines).
History of excessive exercise (greater than 10 hours a week).
Girls will be excluded because there are no data regarding FSH use in children.
Smokers.
Pregnant.
Breast feeding.
Persistent ovarian masses.
History of tumors of the ovary, breast, uterus, hypothalamus, or pituitary.
History of breast or endometrial cancer.
History of hypersensitivity to recombinant FSH or any one of its excipients.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00006156
Study Brief:
Protocol Section:
NCT00006156