Completed

NCT Number: NCT01403675

Human Ovarian Autotransplantation

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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Key information

Conditions

Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ovarian autotransplantation

Procedure

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Samuel Kim, MD

Other

Registry information

Official study title

Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Jul 27, 2011
Registry last updated: Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.