|
Feasibility Study for Development of an Early Test for Ovarian Failure Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Feasibility Study for Development of an Early Test for Ovarian Failure conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Feasibility Study for Development of an Early Test for Ovarian Failure Clinical research trials and Feasibility Study for Development of an Early Test for Ovarian Failure medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Feasibility Study for Development of an Early Test for Ovarian Failure. Feasibility Study for Development of an Early Test for Ovarian Failure Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Feasibility Study for Development of an Early Test for Ovarian Failure clinical trial. Test subjects typically obtain the finest healthcare available for their Feasibility Study for Development of an Early Test for Ovarian Failure condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Feasibility Study for Development of an Early Test for Ovarian Failure  Feasibility Study for Development of an Early Test for Ovarian Failure
Feasibility Study for Development of an Early Test for Ovarian Failure
For Condition: Premature Ovarian Failure,Healthy
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: This is a pilot project to test the feasibility of developing a FSH stimulation test. There is a need for a sensitive and specific marker to detect ovarian insufficiency early in its course. By the time we see young women with idiopathic premature ovarian failure two thirds of them have osteopenia and nearly one in ten have established osteoporosis. Many of these patients describe the onset of menstrual abnormalities several years before the diagnosis of premature ovarian failure becomes apparent. At present this delay in diagnosis is understandable since there are no obvious signs to distinguish impending ovarian failure from "functional" menstrual cycle disturbances. FSH stimulates inhibin B production by the granulosa cells of the cohort of ovarian follicles; serum inhibin B in turn participates in the negative feedback loop regulating FSH secretion. This protocol will characterize the normal FSH-stimulated serum inhibin B response and test the hypothesis that FSH stimulated serum inhibin B levels decline with age in normal women with proven fertility. Initially, ten normal women in each age group (18-25, 26-30, 31-35, 36-40, 41-45, 46-50, 51-55, and 60 or older) will be given 300 IU of recombinant human FSH in a single dose. Blood will drawn for inhibin B, FSH, and estradiol determination at 24, 36, and 48 hours after the FSH injection. A transvaginal ultrasound will also be performed at baseline and at 48 hours after the FSH injection. We expect that the FSH-stimulated serum inhibin B response will predictably track with the decline in ovarian follicle number associated with aging. If so, the test would hold promise as a clinical means by which to detect ovarian insufficiency earlier in its course. Therefore, the results of this study may define parameters that could lead to earlier diagnosis and treatment of premature ovarian insufficiency.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Women with normal ovarian function: Age 18 to 55. Proven fertility (as evidenced by a history of pregnancy regardless of outcome). Normal body mass index (18-27 kg/m2). 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) (34). Postmenopausal women (to serve as negative controls for the FSH stimulation test): 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 (18-27 kg/m2). Naturally menopausal: amenorrhea for at least one year; serum FSH 40 IU/mL. EXCLUSION CRITERIA: 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.
Total Enrollment: 220
Location and Contact Information:
National Institute of Child Health and Human Development (NICHD) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000189; 00-CH-0189
Study Start Date: August 3, 2000
Record last reviewed: May 29, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006156
Other Premature Ovarian Failure Studies:
1. Steroid Therapy in Autoimmune Premature Ovarian Failure
2. Ovarian Follicle Function in Patients with Premature Ovarian Failure
3. Feasibility Study for Development of an Early Test for Ovarian Failure
4. Hormone Replacement in Young Women with Premature Ovarian Failure
Related Studies:
Other Premature Ovarian Failure Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Feasibility Study for Development of an Early Test for Ovarian Failure
|
|
|
|
|
|
|
|
