Human Ovarian Autotransplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403675
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Samuel Kim, MD, University of Kansas Medical Center

July 14, 2011
July 27, 2011
December 4, 2014
May 2009
March 2014   (Final data collection date for primary outcome measure)
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
We will analyze 20 patients if any changes in breast cells afer controlled ovarian stimulation by comparing the results of baseline FNA of breast and repeat FNA [ Time Frame: 6, 12, 18 months ]
Complete list of historical versions of study NCT01403675 on Archive Site
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Human Ovarian Autotransplantation
Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer

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.

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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
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.
Experimental: Ovarian autotransplantation
Intervention: Procedure: Ovarian autotransplantation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Samuel Kim, MD, University of Kansas Medical Center
Samuel Kim, MD
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Principal Investigator: Sam Kim, MD The University of Kansas Medical Center
University of Kansas Medical Center
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP