Feasibility Study for Development of an Early Test for Ovarian Failure
Healthy · Premature Ovarian Failure
Bottom Line
View on ClinicalTrials.gov: NCT00006156 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control (Other); Drug: FSH (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels. |
50.7; 48.8; 96.6; 47.7 | — |
| SECONDARY Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels |
29.9; 25.0; 70.8; 28.3 | — |
Summary
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.
Data sourced from ClinicalTrials.gov (NCT00006156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.