Ovarian Stem Cells From Women With Ovarian Insufficiency

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01702935
First received: October 6, 2012
Last updated: June 14, 2014
Last verified: August 2013

October 6, 2012
June 14, 2014
September 2012
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The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.
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Complete list of historical versions of study NCT01702935 on ClinicalTrials.gov Archive Site
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Ovarian Stem Cells From Women With Ovarian Insufficiency
Oogonial Stem Cell Isolation in Ovarian Insufficiency Patients

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.

Early loss of human ovarian function results in a clinical condition known as primary ovarian insufficiency (POI) or premature ovarian failure (POF). This devastating condition renders women unable to have their own genetic child in more than 95% of cases, as well as failure of hormonal production by the ovary that is critical in maintaining bone health, restful sleep, and quality of life. Indeed, in more carefully designed studies where control groups were used, only 1.5% of POI patients became pregnant, which may more accurately represent the true fertility rate in this population. Currently, fertility treatments for these patients are primarily to use an egg donated from a young woman.

Until recently, it was thought that women were born with a limited number of eggs, which were slowly depleted each month until exhaustion at the time of menopause. However, recent studies have suggested that new eggs can be made from adult stem cells in the ovary. These ovarian stem cells could be transplanted into a recipient mouse, who then delivered donor derived offspring. Recently, ovarian germline stem cell (i.e., oogonial stem cell) isolation has been reported from human ovaries. However, it is not known if oogonial stem cell problems play a part in diseases such as premature ovarian failure or diminished ovarian reserve.

The goal of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency (POI)/failure (POF) and diminished ovarian reserve (DOR). Ovarian biopsies from patients with this disorder will be harvested by laparoscopy, and oogonial stem cells will be isolated in the laboratory and characterized.

Observational
Time Perspective: Prospective
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Infertility
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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  • INCLUSION CRITERIA:

Subject is able to give consent/assent to participate in the protocol.

Listed below are acceptable medical conditions for inclusion in this protocol:

  • Females older than 18 years
  • Clinical etiologies of POI and DOR. (These 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

EXCLUSION CRITERIA:

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.

Female
18 Years and older
No
Contact: Erin F Wolff, M.D. (301) 496-5800 erin.wolff@nih.gov
United States
 
NCT01702935
120212, 12-CH-0212
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Erin F Wolff, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP