Human Ovarian Autotransplantation
|ClinicalTrials.gov Identifier: NCT01403675|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : December 4, 2014
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 or disease||Intervention/treatment||Phase|
|Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer||Procedure: Ovarian autotransplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|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.
- Comparision of orthotopic and heterotopic autotransplantation [ Time Frame: 2009-2015 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403675
|United States, Kansas|
|The University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Sam Kim, MD||The University of Kansas Medical Center|