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Ovarian Follicle Function in Patients With Primary Ovarian Failure

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Disease Information

Descriptive Information
Brief Title † Ovarian Follicle Function in Patients With Primary Ovarian Failure
Official Title † Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency
Brief 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.
Detailed 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.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Amenorrhea Hypoaldosteronism Hypogonadism Infertility Premature Ovarian Failure
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 1134
Start Date † May 12, 1991
Completion Date February 8, 2017
Primary Completion Date
Eligibility Criteria † - 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.
Gender Female
Ages 18 Years - 42 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00001275
Organization ID 910127
Secondary IDs †† 91-CH-0127
Responsible Party Sponsor
Study Sponsor † Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ††
Investigators † Principal Investigator: Lawrence M Nelson, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information Provided By
Verification Date February 8, 2017
First Received Date † November 3, 1999
Last Updated Date April 19, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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