Ovarian Stem Cells From Women With Ovarian Insufficiency

NCT01702935 | Completed

• 2 other identifiers: 12021212-CH-0212
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means that the ovaries are not able to function at a level appropriate for a woman's age. Previously, it was thought that women had only a fixed number of eggs that were lost each month until none were left at menopause. However, recently, stem cells have been found in the ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells may help women with POI in the future. Researchers want to collect ovarian tissue from women with POI to investigate ovarian stem cells. Objectives: \- To collect ovarian tissue from women with primary ovarian insufficiency. Eligibility: \- Women between 18 and 50 years of age with primary ovarian insufficiency. Design:

• Participants will be screened with a physical exam and medical history. They will also have a full gynecological exam. They will provide blood and urine samples.
• Participants will donate ovarian tissue for study. It will be collected through outpatient surgery. The surgery will take either half of an ovary or a full ovary.
• Treatment will not be provided as part of this study.

Conditions

Infertility

Keywords

Ovarian Failure; Premature Ovarian Failure; Infertility; Primary Ovarian Insufficiency; Stem Cells

Outcome Measures

Primary Outcomes (1)

• The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to give consent/assent to participate in the protocol.
• Females older than 18 years with POI, POF, or DOR, undergoing ovarian biopsy by laparoscopy or clinically indicated abdominal surgery that provides access to the ovaries
• Clinical etiologies of POI may include, but are not limited to, idiopathic, autoimmune, chemotherapy related, or Turner s syndrome
• Subjects must have a diagnosis of premature ovarian failure or diminished ovarian reserve as defined by both:
• Early follicular phase FSH \>15 IU/L
• AMH \<0.16 ng/ml or below the level of detection for the assay used
• Females older than 18 years, with or without POI or POF, undergoing clinically indicated ovarian surgery

You may not qualify if:

• Unable to comprehend the investigational nature of the protocol participation
• Positive pregnancy test
• Anticoagulation or known coagulopathy
• Ovarian cancer
• History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would preclude ovarian biopsy
• Previous bowel surgery.

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)

• van Kasteren YM, Schoemaker J. Premature ovarian failure: a systematic review on therapeutic interventions to restore ovarian function and achieve pregnancy. Hum Reprod Update. 1999 Sep-Oct;5(5):483-92. doi: 10.1093/humupd/5.5.483.

  PMID: 10582785 BACKGROUND

• Anasti JN, Kimzey LM, Defensor RA, White B, Nelson LM. A controlled study of danazol for the treatment of karyotypically normal spontaneous premature ovarian failure. Fertil Steril. 1994 Oct;62(4):726-30. doi: 10.1016/s0015-0282(16)56996-9.

  PMID: 7926080 BACKGROUND

• Nelson LM, Kimzey LM, White BJ, Merriam GR. Gonadotropin suppression for the treatment of karyotypically normal spontaneous premature ovarian failure: a controlled trial. Fertil Steril. 1992 Jan;57(1):50-5. doi: 10.1016/s0015-0282(16)54775-x.

  PMID: 1730330 BACKGROUND

MeSH Terms

Conditions

Infertility; Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Alan H DeCherney, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2012
• First Posted: October 10, 2012
• Study Start: September 19, 2012
• Study Completion: September 21, 2017
• Last Updated: December 17, 2019

Record last verified: 2017-09-21

Locations

US (1)