Ovarian Follicle Function in Patients With Primary Ovarian Failure

Infertility Clinical Trial

Official title:

Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001275
• Other study ID #: 910127
• Secondary ID: 91-CH-0127
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: October 5, 2017
• Start date: May 12, 1991
• Est. completion date: February 8, 2017

Study information

• Verified date: February 8, 2017
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with prematurem ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols.

Description:

No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous primary ovarian insufficiency. We know that more than one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This protocol permitted baseline clinical evaluation of patients with primary ovarian insufficiency and ongoing observation of the natural history of the disorder. The protocol is now in the follow up and analysis phase and is not now recruiting new patients. Now a major aim of the protocol is to investigate large scale medical sequencing as a method by which to uncover mechanisms of primary ovarian insufficiency and to assist in the management of women with this condition. This will involve a community-based participatory research approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: February 8, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

• INCLUSION CRITERIA:

Women 18 to 42 years of age with primary ovarian insufficiency who meet the following requirements were candidates for recruitment to the study: 1) at least a four month history of oligo-amenorrhea not due to pregnancy, and 2) clearly elevated gonadotropins in the menopausal range on two separate occasions at least one month apart.

EXCLUSION CRITERIA:

Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency were not candidates.

Related Conditions & MeSH terms

• Amenorrhea
• Hypoaldosteronism
• Hypogonadism
• Infertility
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Anasti JN, Flack MR, Froehlich J, Nelson LM. The use of human recombinant gonadotropin receptors to search for immunoglobulin G-mediated premature ovarian failure. J Clin Endocrinol Metab. 1995 Mar;80(3):824-8. — View Citation

Kim TJ, Anasti JN, Flack MR, Kimzey LM, Defensor RA, Nelson LM. Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1997 May;89(5 Pt 1):777-9. — View Citation

Nelson LM, Anasti JN, Kimzey LM, Defensor RA, Lipetz KJ, White BJ, Shawker TH, Merino MJ. Development of luteinized graafian follicles in patients with karyotypically normal spontaneous premature ovarian failure. J Clin Endocrinol Metab. 1994 Nov;79(5):1470-5. — View Citation