Human Ovarian Autotransplantation

NCT ID: NCT01403675

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Conditions

Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ovarian autotransplantation

Group Type: EXPERIMENTAL

Ovarian autotransplantation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samuel Kim, MD

OTHER

Sponsor Role: lead

Responsible Party

Samuel Kim, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sam Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

The University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

11214

Identifier Type: -

Identifier Source: org_study_id