Feasibility Study for Development of an Early Test for Ovarian Failure

NCT00006156 | Completed Results

• 2 other identifiers: 00018900-CH-0189
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Premature Ovarian Failure

Keywords

Ovarian Failure; Ovary; Aging; Healthy Volunteer; Primary Ovarian Insufficiency(POI); Premature Menopause; Premature Ovarian Failure (POF)

Outcome Measures

Primary Outcomes (1)

• Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.

  24 hours

Secondary Outcomes (1)

• Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels

  24 hours

Study Arms (2)

Control

EXPERIMENTAL

Control for FSH stimulation test

Other: Control

Drug: FSH

EXPERIMENTAL

FSH Stimulation Test

Drug: Drug: FSH

Interventions

Control OTHER

No injection of FSH

Control

Drug: FSH DRUG

FSH Stimulation Test

Drug: FSH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• to 200 CGG repeats.
• Normal menstrual cycles (between 25-35 days in length).
• Have previously had genetic counseling regarding their FMR1 status.

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Institutes of Health Clinical Center (CC): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 9464713 BACKGROUND

• Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.

  PMID: 3960433 BACKGROUND

• 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.

  PMID: 8671489 BACKGROUND

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Menopause, Premature

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Nelson, Lawrence Merle
• Organization: National Institute of Child Health and Human Development

nelsonl@mail.nih.gov

+1 301 402 6608

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2000
• First Posted: August 10, 2000
• Study Start: August 1, 2000
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 16, 2013
• Results First Posted: May 16, 2013

Record last verified: 2013-03

Locations

US (1)