Completed

Ovarian Follicle Function in Patients With Primary Ovarian Failure

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What is being collected

Data Collection

Who is being recruted

Amenorrhea
+2

+ Hypoaldosteronism
+ Hypogonadism
From 18 to 42 Years

See all eligibility criteria

How is the trial designed

Other

Observational
Study Start: May 1991

See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: October 6, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: May 12, 1991Actual date on which the first participant was enrolled.

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. 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.

Official TitleOvarian Follicle Function in Patients With Primary Ovarian Insufficiency 
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: October 6, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1134 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 42 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Amenorrhea
Hypoaldosteronism
Hypogonadism
Infertility
Premature Ovarian Failure
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United StatesSee the location
CompletedOne Study Center
Ovarian Follicle Function in Patients With Primary Ovarian Failure | PatLynk