Ovarian Follicle Function in Patients With Premature Ovarian Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001275
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

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
Amenorrhea
Hypoaldosteronism
Hypogonadism
Infertility
Premature Ovarian Failure

Study Type: Observational
Official Title: Ovarian Follicle Function in Patients With Premature Ovarian Failure

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 1134
Study Start Date: May 1991
Detailed Description:

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 premature ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Women 18 to 45 years of age with premature ovarian failure who meet the following requirements will be candidates for the study: 1) at least a four month history of amenorrhea not due to pregnancy, and 2) at least two documented serum FSH levels or two documented LH levels in the menopausal range for the corresponding assay (greater than or equal to 20 U/ml for FSH and greater than or equal to15 U/L for LH in the current Clinical Center assays).

EXCLUSION CRITERIA:

Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian failure will not be candidates.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001275

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Lawrence M Nelson, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001275     History of Changes
Other Study ID Numbers: 910127, 91-CH-0127
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Menopause
Estrogen
Infertility
Ovulation
Amenorrhea
Hypergonadotropic Hypogonadism
Young Women
Gonadal Steroid Deficiency
Mineralocorticoid Deficiency
Premature Ovarian Failure
POF

Additional relevant MeSH terms:
Amenorrhea
Hypoaldosteronism
Hypogonadism
Infertility
Menopause, Premature
Primary Ovarian Insufficiency
Menstruation Disturbances
Pathologic Processes
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on August 28, 2014