Ovarian Follicle Function in Patients With Primary Ovarian Failure



Status:Completed
Conditions:Women's Studies, Endocrine, Infertility
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - 42
Updated:10/8/2017
Start Date:May 12, 1991
End Date:February 8, 2017

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Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency

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.

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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