Ovarian Follicle Function in Patients With Primary Ovarian Failure

NCT00001275 | Completed

• 2 other identifiers: 91012791-CH-0127
• Study Type: observational
• Target: 1,134
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency were not candidates.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 7962345 BACKGROUND

• 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.

  PMID: 7883837 BACKGROUND

• 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.

  PMID: 9166320 BACKGROUND

MeSH Terms

Conditions

Amenorrhea; Hypoaldosteronism; Hypogonadism; Infertility; Primary Ovarian Insufficiency; Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Diseases; Urogenital Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Lawrence M Nelson, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: May 12, 1991
• Study Completion: February 8, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-02-08

Locations

US (1)