Trial record 9 of 14 for:    primary ovarian insufficiency | NICHD

Ovarian Follicle Function in Patients With Primary Ovarian Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00001275
First received: November 3, 1999
Last updated: August 29, 2015
Last verified: September 2014
  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 Primary Ovarian Insufficiency

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders 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.

  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:
Responsible Party: National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier: NCT00001275     History of Changes
Other Study ID Numbers: 910127, 91-CH-0127
Study First Received: November 3, 1999
Last Updated: August 29, 2015
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 01, 2015