Human Ovarian Autotransplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Samuel Kim, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01403675
First received: July 14, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors may find that they are not able to produce female hormones, and they may not be able to have a child. Scientists are trying to find ways to help cancer survivors regain their hormonal function and possibly get pregnant, if they desire. Scientists have developed a method where ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back into her body is called ovarian autotransplantation.

Ovarian autotransplantation is a very new technique, and there have only been a small number of women who have had this procedure. So far, only five babies in the world have been born using this technique.

The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope to find better ways to use this method to help a woman's ovaries start working again after chemotherapy. If the ovaries start working again, it might be possible to have a baby.


Condition Intervention
Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
Procedure: Ovarian autotransplantation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Comparision of orthotopic and heterotopic autotransplantation [ Time Frame: 2009-2015 ] [ Designated as safety issue: No ]
    The main purpose of this study is to investigate restoration of ovarian function and fertility by autotransplantation of human ovarian tissue using heterotopic and orthotopic techniques


Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ovarian autotransplantation Procedure: Ovarian autotransplantation
There are two ways to transplant the thawed ovarian tissue back into a woman's body. It can be put back inside the abdomen, close to the natural location of the ovaries, or the tissue can be put under the skin of the abdomen. After you have had the transplant, your hormone function will be tested every month. Each month, you will have a blood draw to measure hormones and an ultrasound to see how the tissue is growing. These monthly visits will continue until you have normal hormone levels. If the transplant is successful, it is expected that your hormones would return to normal in 3 - 7 months. If your hormone levels return and stay regular for three months, then Dr. Kim will talk to you about trying to get pregnant. The method of getting pregnant will depend on the type of transplantation surgery you had and your current medical condition. You will have weekly blood tests and other tests to determine the best way to get pregnant.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult women (age between 18 and 40) who stored the ovary before cancer therapy.
  • Adult women who completed cancer therapy and are in remission.
  • Adult women who desire to conceive and are ready to have a baby.

Exclusion criteria:

  • Age under 18 or over 40 years old
  • Women with a disease at high risk for ovarian metastasis (such as leukemia)
  • Women with contraindication for surgery
  • Women with contraindication for pregnancy
  • Psychological instability to sustain pregnancy (diagnosed by a psychiatrist)
  • Women who are HIV Positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403675

Locations
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Samuel Kim, MD
Investigators
Principal Investigator: Sam Kim, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: Samuel Kim, MD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01403675     History of Changes
Other Study ID Numbers: 11214
Study First Received: July 14, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
women with cancer whose ovarian tissue has been collected and stored in liquid nitrogen before cancer therapy (surgery, chemotherapy, radiotherapy),
who are in remission (no recurrence of disease for 5 years),
who are in normal organ function and have no contraindication for surgery or pregnancy, and
who wish to restore ovarian function using stored ovarian tissue.

ClinicalTrials.gov processed this record on October 16, 2014