<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/NCT02225145</url>
  </required_header>
  <id_info>
    <org_study_id>140177</org_study_id>
    <secondary_id>14-CH-0177</secondary_id>
    <nct_id>NCT02225145</nct_id>
  </id_info>
  <brief_title>Fertility Preservation in Women Who Will Have Gonadotoxic Therapy or Hematopoetic Stem Cell Transplantation, and in Women With Sickle Cell Disease</brief_title>
  <official_title>Fertility Preservation in Females Who Will be Undergoing Gonadotoxic Therapy, Hematopoietic Stem Cell Transplantation, and in Females With Sickle Cell Disease</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;
      - Some treatments for cancer or other diseases can lead to infertility in women. These&#xD;
      treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They&#xD;
      are called gonadotoxic therapies. Women can now have their eggs frozen before they have these&#xD;
      treatments. This may allow them to get pregnant later. Researchers want to learn more about&#xD;
      this technology and processes.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about&#xD;
      the effects of these therapies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Women at least 18 years old who are past puberty and before menopause. They must be&#xD;
      scheduled to have gonadotoxic therapies.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with medical history and blood and hormone tests. They&#xD;
           will also have a physical exam and transvaginal ultrasound.&#xD;
&#xD;
        -  Ovary stimulation: participants will have medications injected under the skin. These&#xD;
           increase the chance of fertility. This phase will take about 8 20 days. Participants&#xD;
           will have blood drawn and transvaginal ultrasound daily or every other day. Some&#xD;
           participants will also have blood thinner injected daily.&#xD;
&#xD;
        -  Egg retrieval: participants will check in to the hospital. Eggs will be removed with a&#xD;
           needle during a short surgery. Participants will be awake but sedated.&#xD;
&#xD;
        -  Participants may stay overnight in the hospital.&#xD;
&#xD;
        -  They will return every 1 3 days for 1 3 weeks for blood tests.&#xD;
&#xD;
        -  Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be&#xD;
           fertilized for clinical use) will be used for research. Participants can use their eggs&#xD;
           in the future at outside, private fertility clinics to try to become pregnant. If the&#xD;
           eggs are stored for more than 5 years, participants must pay for storage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment with chemotherapeutic drugs, hematopoietic stem cell transplantation, and pelvic&#xD;
      radiotherapy for cancer or other serious medical illnesses has the potential to markedly&#xD;
      increase the risk of gonadotoxicity leading to infertility in women. Females who are&#xD;
      post-menarchal with these risk factors may be candidates for fertility preservation through&#xD;
      oocyte cryopreservation before ovarian failure ensues. For example, sickle cell disease (SCD)&#xD;
      is the most common hemoglobinopathy in the United States (3). Hypoxic conditions cause the&#xD;
      abnormal hemoglobin molecule to undergo sickling which leads to painful microvascular&#xD;
      occlusion. SCD is associated with multiple organ system dysfunction as well as neurological&#xD;
      and pulmonary complications, which can lead to early mortality. Hematopoietic stem cell&#xD;
      transplantation (HSCT) is the only treatment currently available for SCD that results in a&#xD;
      complete cure. In patients who have undergone HSCT with a matched sibling, event-free&#xD;
      survival has been as high as 85%-95%. Multiple studies have unfortunately demonstrated that&#xD;
      infertility and premature ovarian insufficiency are quite common following HSCT. Specifically&#xD;
      in our patient population with sickle cell disease, we have recently found largely preserved&#xD;
      ovarian function prior to transplantation, but profound gonadotoxicity following transplant&#xD;
      (unpublished). This underscores the clinical need for additional, effective fertility&#xD;
      preservation methods for our at-risk populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 15, 2014</start_date>
  <completion_date type="Actual">September 20, 2017</completion_date>
  <primary_completion_date type="Actual">September 9, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oocyte vitrification</measure>
    <time_frame>End of Stumulation</time_frame>
  </primary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Hemoglobin</condition>
  <condition>Stem Cell Transplant</condition>
  <condition>Aplastic Anemia</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Subject is able to give consent/assent to participate in the protocol:&#xD;
&#xD;
          -  Post-Menarchal females greater than or equal to 7 years old undergoing gonadotoxic&#xD;
             therapy, hematopoietic stem cell transplantation, and/or sickle cell disease&#xD;
&#xD;
          -  Have a FSH less than or equal to 13 mIU/ml or AMH greater than or equal to 0.5 ng/ml&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Unable to comprehend the investigational nature of the protocol&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Ovarian cancer&#xD;
&#xD;
          -  Diagnosis of HIV/AIDS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>45 Years</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>Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. doi: 10.1016/j.fertnstert.2012.09.028. Epub 2012 Oct 22.</citation>
    <PMID>23083924</PMID>
  </reference>
  <reference>
    <citation>Practice Committee of American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2013 Nov;100(5):1214-23. doi: 10.1016/j.fertnstert.2013.08.012. Epub 2013 Sep 5.</citation>
    <PMID>24011612</PMID>
  </reference>
  <reference>
    <citation>Dovey S, Krishnamurti L, Sanfilippo J, Gunawardena S, Mclendon P, Campbell M, Alway S, Efymow B, Gracia C. Oocyte cryopreservation in a patient with sickle cell disease prior to hematopoietic stem cell transplantation: first report. J Assist Reprod Genet. 2012 Mar;29(3):265-9. doi: 10.1007/s10815-011-9698-2. Epub 2012 Jan 5.</citation>
    <PMID>22219083</PMID>
  </reference>
  <verification_date>September 20, 2017</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>May 31, 2018</last_update_submitted>
  <last_update_submitted_qc>May 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone Marrow Transplant</keyword>
  <keyword>Fertility</keyword>
  <keyword>Ovary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
    <mesh_term>Anemia, Aplastic</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/NCT02225145
org study id: 140177
secondary id: 14-CH-0177
nct id: NCT02225145
lead sponsor: 
Background:

      - Some treatments for cancer or other diseases can lead to infertility in women. These
      treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They
      are called gonadotoxic therapies. Women can now have their eggs frozen before they have these
      treatments. This may allow them to get pregnant later. Researchers want to learn more about
      this technology and processes.

      Objectives:

      - To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about
      the effects of these therapies.

      Eligibility:

      - Women at least 18 years old who are past puberty and before menopause. They must be
      scheduled to have gonadotoxic therapies.

      Design:

        -  Participants will be screened with medical history and blood and hormone tests. They
           will also have a physical exam and transvaginal ultrasound.

        -  Ovary stimulation: participants will have medications injected under the skin. These
           increase the chance of fertility. This phase will take about 8 20 days. Participants
           will have blood drawn and transvaginal ultrasound daily or every other day. Some
           participants will also have blood thinner injected daily.

        -  Egg retrieval: participants will check in to the hospital. Eggs will be removed with a
           needle during a short surgery. Participants will be awake but sedated.

        -  Participants may stay overnight in the hospital.

        -  They will return every 1 3 days for 1 3 weeks for blood tests.

        -  Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be
           fertilized for clinical use) will be used for research. Participants can use their eggs
           in the future at outside, private fertility clinics to try to become pregnant. If the
           eggs are stored for more than 5 years, participants must pay for storage.
Treatment with chemotherapeutic drugs, hematopoietic stem cell transplantation, and pelvic
      radiotherapy for cancer or other serious medical illnesses has the potential to markedly
      increase the risk of gonadotoxicity leading to infertility in women. Females who are
      post-menarchal with these risk factors may be candidates for fertility preservation through
      oocyte cryopreservation before ovarian failure ensues. For example, sickle cell disease (SCD)
      is the most common hemoglobinopathy in the United States (3). Hypoxic conditions cause the
      abnormal hemoglobin molecule to undergo sickling which leads to painful microvascular
      occlusion. SCD is associated with multiple organ system dysfunction as well as neurological
      and pulmonary complications, which can lead to early mortality. Hematopoietic stem cell
      transplantation (HSCT) is the only treatment currently available for SCD that results in a
      complete cure. In patients who have undergone HSCT with a matched sibling, event-free
      survival has been as high as 85%-95%. Multiple studies have unfortunately demonstrated that
      infertility and premature ovarian insufficiency are quite common following HSCT. Specifically
      in our patient population with sickle cell disease, we have recently found largely preserved
      ovarian function prior to transplantation, but profound gonadotoxicity following transplant
      (unpublished). This underscores the clinical need for additional, effective fertility
      preservation methods for our at-risk populations.
observational model: Cohort
time perspective: Prospective
measure: Oocyte vitrification
time frame: End of Stumulation
criteria: 
gender: All
minimum age: 7 Years
maximum age: 45 Years
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: Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. doi: 10.1016/j.fertnstert.2012.09.028. Epub 2012 Oct 22.
PMID: 23083924
citation: Practice Committee of American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2013 Nov;100(5):1214-23. doi: 10.1016/j.fertnstert.2013.08.012. Epub 2013 Sep 5.
PMID: 24011612
citation: Dovey S, Krishnamurti L, Sanfilippo J, Gunawardena S, Mclendon P, Campbell M, Alway S, Efymow B, Gracia C. Oocyte cryopreservation in a patient with sickle cell disease prior to hematopoietic stem cell transplantation: first report. J Assist Reprod Genet. 2012 Mar;29(3):265-9. doi: 10.1007/s10815-011-9698-2. Epub 2012 Jan 5.
PMID: 22219083
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
mesh term: Anemia, Aplastic