- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00006156
Feasibility Study for Development of an Early Test for Ovarian Failure
FSH-Stimulated Inhibin B as a Marker for Early Ovarian Insufficiency
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.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Control
Control for FSH stimulation test
|
No injection of FSH
|
실험적: Drug: FSH
FSH Stimulation Test
|
FSH Stimulation Test
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.
기간: 24 hours
|
24 hours
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels
기간: 24 hours
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24 hours
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.
- Anasti JN, Kalantaridou SN, Kimzey LM, Defensor RA, Nelson LM. Bone loss in young women with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1998 Jan;91(1):12-5. doi: 10.1016/s0029-7844(97)00583-8.
- Faddy MJ, Gosden RG. A model conforming the decline in follicle numbers to the age of menopause in women. Hum Reprod. 1996 Jul;11(7):1484-6. doi: 10.1093/oxfordjournals.humrep.a019422.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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