Overview

This trial is active, not recruiting.

Conditions amenorrhea, hypoaldosteronism, hypogonadism, infertility, premature ovarian failure
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date May 1991
Trial size 1134 participants
Trial identifier NCT00001275, 91-CH-0127, 910127

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.

United States No locations recruiting
Other Countries No locations recruiting

Eligibility Criteria

Female participants from 18 years up to 42 years old.

- 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.

Additional Information

Official title Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency
Principal investigator Lawrence M Nelson, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC).