Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for CancerNCT01403675
Human Ovarian Autotransplantation
A study testing Ovarian autotransplantation in people with Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer, run by Samuel Kim, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
- What is being tested?
- Ovarian autotransplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
- Conditions
- Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
- Being tested
- Ovarian autotransplantation
- Keywords
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian autotransplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian autotransplantation | Experimental | Not described Receives: Procedure: Ovarian autotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparision of orthotopic and heterotopic autotransplantation
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
Measured: 2009-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Kim, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Kim, MD, University of Kansas Medical Center
- Investigators
- Sam Kim, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403675
- Sponsor's protocol ID
- 11214
- Status last verified
- Dec 2014
- First submitted
- 14 Jul 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
- ClinicalTrials.gov ID
- NCT01403675
- Acronym / sponsor ID
- 11214
- Conditions
- Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
- Keywords
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Samuel Kim, MDUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian autotransplantation | Experimental | Procedure: Ovarian autotransplantation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian autotransplantationThere 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. | Procedure or surgery | Ovarian autotransplantation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Kim, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian autotransplantation in people with Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer, run by Samuel Kim, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparision of orthotopic and heterotopic autotransplantation (time frame: 2009-2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014; AzTrials last refreshed its copy on 29 Oct 2026.