Ovarian Stem Cells From Women With Ovarian Insufficiency

December 14, 2019 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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 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:

      1. Early follicular phase FSH >15 IU/L
      2. 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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 19, 2012

Study Completion

September 21, 2017

Study Registration Dates

First Submitted

October 6, 2012

First Submitted That Met QC Criteria

October 6, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 14, 2019

Last Verified

September 21, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120212
  • 12-CH-0212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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