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Ovarian Follicle Function in Patients With Primary Ovarian Failure

Primary Purpose

Amenorrhea, Hypoaldosteronism, Hypogonadism

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Amenorrhea focused on measuring Menopause, Estrogen, Infertility, Ovulation, Amenorrhea, Hypergonadotropic Hypogonadism, Young Women, Gonadal Steroid Deficiency, Mineralocorticoid Deficiency, Premature Ovarian Failure, POF

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
October 5, 2017
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00001275
Brief Title
Ovarian Follicle Function in Patients With Primary Ovarian Failure
Official Title
Ovarian Follicle Function in Patients With Primary Ovarian Insufficiency
Study Type
Observational

2. Study Status

Record Verification Date
February 8, 2017
Overall Recruitment Status
Completed
Study Start Date
May 12, 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 8, 2017 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea, Hypoaldosteronism, Hypogonadism, Infertility, Premature Ovarian Failure
Keywords
Menopause, Estrogen, Infertility, Ovulation, Amenorrhea, Hypergonadotropic Hypogonadism, Young Women, Gonadal Steroid Deficiency, Mineralocorticoid Deficiency, Premature Ovarian Failure, POF

7. Study Design

Enrollment
1134 (Actual)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence M Nelson, M.D.
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7962345
Citation
Nelson LM, Anasti JN, Kimzey LM, Defensor RA, Lipetz KJ, White BJ, Shawker TH, Merino MJ. Development of luteinized graafian follicles in patients with karyotypically normal spontaneous premature ovarian failure. J Clin Endocrinol Metab. 1994 Nov;79(5):1470-5. doi: 10.1210/jcem.79.5.7962345.
Results Reference
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PubMed Identifier
7883837
Citation
Anasti JN, Flack MR, Froehlich J, Nelson LM. The use of human recombinant gonadotropin receptors to search for immunoglobulin G-mediated premature ovarian failure. J Clin Endocrinol Metab. 1995 Mar;80(3):824-8. doi: 10.1210/jcem.80.3.7883837.
Results Reference
background
PubMed Identifier
9166320
Citation
Kim TJ, Anasti JN, Flack MR, Kimzey LM, Defensor RA, Nelson LM. Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1997 May;89(5 Pt 1):777-9. doi: 10.1016/s0029-7844(97)00077-x.
Results Reference
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Ovarian Follicle Function in Patients With Primary Ovarian Failure

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