<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702935</url>
  </required_header>
  <id_info>
    <org_study_id>120212</org_study_id>
    <secondary_id>12-CH-0212</secondary_id>
    <nct_id>NCT01702935</nct_id>
  </id_info>
  <brief_title>Ovarian Stem Cells From Women With Ovarian Insufficiency</brief_title>
  <official_title>Oogonial Stem Cell Isolation in Ovarian Insufficiency Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means&#xD;
      that the ovaries are not able to function at a level appropriate for a woman's age.&#xD;
      Previously, it was thought that women had only a fixed number of eggs that were lost each&#xD;
      month until none were left at menopause. However, recently, stem cells have been found in the&#xD;
      ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells&#xD;
      may help women with POI in the future. Researchers want to collect ovarian tissue from women&#xD;
      with POI to investigate ovarian stem cells.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To collect ovarian tissue from women with primary ovarian insufficiency.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Women between 18 and 50 years of age with primary ovarian insufficiency.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with a physical exam and medical history. They will also&#xD;
           have a full gynecological exam. They will provide blood and urine samples.&#xD;
&#xD;
        -  Participants will donate ovarian tissue for study. It will be collected through&#xD;
           outpatient surgery. The surgery will take either half of an ovary or a full ovary.&#xD;
&#xD;
        -  Treatment will not be provided as part of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early loss of human ovarian function results in a clinical condition known as primary ovarian&#xD;
      insufficiency (POI) or premature ovarian failure (POF). This devastating condition renders&#xD;
      women unable to have their own genetic child in more than 95% of cases (1), as well as&#xD;
      failure of hormonal production by the ovary that is critical in maintaining bone health,&#xD;
      restful sleep, and quality of life. Indeed, in more carefully designed studies where control&#xD;
      groups were used, only 1.5% of POI patients became pregnant (2-8), which may more accurately&#xD;
      represent the true fertility rate in this population. Currently, fertility treatments for&#xD;
      these patients are primarily to use an egg donated from a young woman&#xD;
&#xD;
      Until recently, it was thought that women were born with a limited number of eggs, which were&#xD;
      slowly depleted each month until exhaustion at the time of menopause. However, recent studies&#xD;
      have suggested that new eggs can be made from adult stem cells in the ovary. (1, 2) These&#xD;
      ovarian stem cells could be transplanted into a recipient mouse, who then delivered donor&#xD;
      derived offspring (3). Recently, ovarian germline stem cell (i.e., oogonial stem cell)&#xD;
      isolation has been reported from human ovaries (12).(4). However, it is not known if oogonial&#xD;
      stem cell problems play a part in diseases such as premature ovarian failure or diminished&#xD;
      ovarian reserve.&#xD;
&#xD;
      The goal of this protocol is to characterize oogonial stem cells in patients with primary&#xD;
      ovarian insufficiency (POI)/failure (POF) and diminished ovarian reserve (DOR). There will be&#xD;
      three groups in this study: patients with POI or POF undergoing ovarian biopsy by&#xD;
      laparoscopy, patients with POI or POF undergoing clinically indicated abdominal surgery that&#xD;
      provides access to the ovaries, and patients over 18 undergoing clinically indicated ovarian&#xD;
      surgery (with or without POI or POF). Ovarian biopsies will be harvested by laparoscopy or at&#xD;
      the time of indicated surgery, and oogonial stem cells will be isolated in the laboratory and&#xD;
      characterized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 19, 2012</start_date>
  <completion_date>September 21, 2017</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.</measure>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Infertility</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Subject is able to give consent/assent to participate in the protocol.&#xD;
&#xD;
        Listed below are acceptable medical conditions for inclusion in this protocol:&#xD;
&#xD;
          -  Females older than 18 years with POI, POF, or DOR, undergoing ovarian biopsy by&#xD;
             laparoscopy or clinically indicated abdominal surgery that provides access to the&#xD;
             ovaries&#xD;
&#xD;
               -  Clinical etiologies of POI may include, but are not limited to, idiopathic,&#xD;
                  autoimmune, chemotherapy related, or Turner s syndrome&#xD;
&#xD;
               -  Subjects must have a diagnosis of premature ovarian failure or diminished ovarian&#xD;
                  reserve as defined by both:&#xD;
&#xD;
                    1. Early follicular phase FSH &gt;15 IU/L&#xD;
&#xD;
                    2. AMH &lt;0.16 ng/ml or below the level of detection for the assay used&#xD;
&#xD;
          -  Females older than 18 years, with or without POI or POF, undergoing clinically&#xD;
             indicated ovarian surgery&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Unable to comprehend the investigational nature of the protocol participation&#xD;
&#xD;
        Positive pregnancy test&#xD;
&#xD;
        Anticoagulation or known coagulopathy&#xD;
&#xD;
        Ovarian cancer&#xD;
&#xD;
        History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would&#xD;
        preclude ovarian biopsy&#xD;
&#xD;
        Previous bowel surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan H DeCherney, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>10582785</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>7926080</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1730330</PMID>
  </reference>
  <verification_date>September 21, 2017</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>December 14, 2019</last_update_submitted>
  <last_update_submitted_qc>December 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Failure</keyword>
  <keyword>Premature Ovarian Failure</keyword>
  <keyword>Infertility</keyword>
  <keyword>Primary Ovarian Insufficiency</keyword>
  <keyword>Stem Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702935
org study id: 120212
secondary id: 12-CH-0212
nct id: NCT01702935
lead sponsor: 
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 (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.
time perspective: Prospective
measure: The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan H DeCherney, M.D.
role: Principal Investigator
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
facility: 
country: United States
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Infertility