Ovarian Follicle Function in Patients With Primary Ovarian Failure
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| ClinicalTrials.gov Identifier: NCT00001275 |
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Recruitment Status :
Completed
First Posted : November 4, 1999
Last Update Posted : October 6, 2017
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Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
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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.
| Condition or disease |
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| Amenorrhea Hypoaldosteronism Hypogonadism Infertility Premature Ovarian Failure |
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 Type : | Observational |
| Actual Enrollment : | 1134 participants |
| Official Title: | Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency |
| Study Start Date : | May 12, 1991 |
| Study Completion Date : | February 8, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Corticosterone methyloxidase deficiency
MedlinePlus related topics:
Primary Ovarian Insufficiency
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 42 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001275
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Lawrence M Nelson, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Publications:
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00001275 |
| Other Study ID Numbers: |
910127 91-CH-0127 |
| First Posted: | November 4, 1999 Key Record Dates |
| Last Update Posted: | October 6, 2017 |
| Last Verified: | February 8, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
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Premature Ovarian Failure Menopause Estrogen Infertility Ovulation Amenorrhea |
Hypergonadotropic Hypogonadism Young Women Gonadal Steroid Deficiency Mineralocorticoid Deficiency POF |
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency Ovarian Diseases Adrenal Insufficiency Infertility Menopause, Premature Hypogonadism Hypoaldosteronism Amenorrhea Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Genital Diseases Gonadal Disorders Endocrine System Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Menstruation Disturbances Pathologic Processes Adrenal Gland Diseases |