Feasibility Study for Development of an Early Test for Ovarian Failure
Completed · Not applicable
Conditions studied: Healthy, Premature Ovarian Failure
In brief
This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure. The ovaries produce female hormones, such as estrogen, that are important in maintaining a woman's health. When the ovaries do not work properly, problems can develop. Unfortunately, there is no test that can detect ovarian failure early in its course. By the time premature ovarian failure is diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that weakens bones and increases the risk of fractures. Women with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and vaginal ultrasound examination. For the ultrasound study, a probe that emits sound waves is inserted into the vagina, and the sound waves are converted to form images of the ovaries. The procedure is done with an empty bladder and takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study will return to the NIH Clinical Center for the following additional procedures: Visit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are still menstruating). Participants will have blood tests to measure hormone levels and to check for pregnancy, and will have another transvaginal ultrasound examination. They will then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a hormone the body makes normally. Visits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2 for collection of blood samples. Visit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and a final transvaginal ultrasound examination.
Key facts
- Study ID
- NCT00006156
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 49
- Starts
- 2000-08-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2013-05-16
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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