Ovarian Follicle Function in Patients With Primary Ovarian Failure

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.

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Key information

Conditions

Amenorrhea Adnexal Diseases Adrenal Gland Diseases Adrenal Insufficiency Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hypoaldosteronism Hypogonadism Infertility Menstruation Disturbances Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Ovarian Failure Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency

Important dates

Study start: 1991
Study completion: 2017
First posted: Nov 4, 1999
Registry last updated: Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed