Ovarian Stem Cells From Women With Ovarian Insufficiency
|First Received Date ICMJE||October 6, 2012|
|Last Updated Date||November 11, 2014|
|Start Date ICMJE||September 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01702935 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Ovarian Stem Cells From Women With Ovarian Insufficiency|
|Official Title ICMJE||Oogonial Stem Cell Isolation in Ovarian Insufficiency Patients|
- 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.
- To collect ovarian tissue from women with primary ovarian insufficiency.
- Women between 18 and 50 years of age with primary ovarian insufficiency.
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 (1), 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 (2-8), 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. (1, 2) These ovarian stem cells could be transplanted into a recipient mouse, who then delivered donor derived offspring (3). Recently, ovarian germline stem cell (i.e., oogonial stem cell) isolation has been reported from human ovaries (12).(4). 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). There will be three groups in this study: patients with POI or POF undergoing ovarian biopsy by laparoscopy, patients with POI or POF undergoing clinically indicated abdominal surgery that provides access to the ovaries, and patients over 18 undergoing clinically indicated ovarian surgery (with or without POI or POF). Ovarian biopsies will be harvested by laparoscopy or at the time of indicated surgery, and oogonial stem cells will be isolated in the laboratory and characterized.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||50|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subject is able to give consent/assent to participate in the protocol.
Listed below are acceptable medical conditions for inclusion in this protocol:
Unable to comprehend the investigational nature of the protocol participation
Positive pregnancy test
Anticoagulation or known coagulopathy
History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would preclude ovarian biopsy
Previous bowel surgery.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01702935|
|Other Study ID Numbers ICMJE||120212, 12-CH-0212|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP