Autologous Ovarian Tissue Transplant for Infertility
What You Need to Know Before You Apply
What is the purpose of this trial?
Chemotherapy and radiation for cancer and other conditions can cause infertility. Several centers around the world are cryopreserving ovarian tissue from these patients though an experimental protocol, including the Fertility Preservation Program in Pittsburgh (protocol PRO08050491). The objective of this study is to study the efficacy and safety of autologous tissue transplantation in patients diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is autologous ovarian tissue transplantation safe for humans?
Research shows that autologous ovarian tissue transplantation, which involves freezing and later transplanting ovarian tissue, is generally considered safe for humans. Studies have been conducted on women with various conditions, and the procedure has been used to restore fertility and delay menopause, with no major safety concerns reported.12345
How is the treatment of autologous ovarian tissue transplant for infertility unique compared to other treatments?
Autologous ovarian tissue transplant is unique because it involves transplanting a woman's own previously frozen ovarian tissue back into her body, which can restore fertility after treatments like chemotherapy that may damage the ovaries. This method is particularly promising for preserving fertility in young girls and women who cannot delay cancer treatment, as it is the only option available for prepubertal girls.56789
What data supports the effectiveness of the treatment Autologous Ovarian Tissue Transplant for Infertility?
Research shows that autologous ovarian tissue transplantation, where a woman's own ovarian tissue is frozen and later transplanted back, is a promising method for preserving fertility, especially in cancer patients. Studies indicate that this treatment can help restore fertility, although outcomes can vary depending on individual factors.1561011
Who Is on the Research Team?
Kyle Orwig, PhD
Principal Investigator
University of Pittsburgh/University of Pittsburgh Medical Center
Are You a Good Fit for This Trial?
This trial is for women who have lost their fertility due to cancer treatments like chemotherapy or radiation and had previously frozen ovarian tissue. They must be in good health, cleared by an oncologist, and either have primary ovarian insufficiency or wish to become pregnant. Women at high surgical risk, with pregnancy contraindications, BRCA mutations, certain cancers, psychological issues preventing consent, or current pregnancy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Eligible subjects complete infectious disease testing and quality of life survey before ovarian tissue thawing and transplantation
Transplantation
Ovarian tissue thawing and transplantation performed via laparoscopy or minilaparotomy
Post-operative Assessment
Assessment within six weeks post-transplant to ensure recovery and emotional well-being
Follow-up
Series of follow-up assessments to monitor reproductive hormone levels, menstrual function, and complications
Long-term Follow-up
Annual survey starting year 3 post-transplantation to collect data on menstrual/pregnancy history and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Ovarian tissue transplant
Ovarian tissue transplant is already approved in European Union, United States, Canada for the following indications:
- Primary ovarian insufficiency after chemotherapy and/or radiation treatments
- Primary ovarian insufficiency after chemotherapy and/or radiation treatments
- Primary ovarian insufficiency after chemotherapy and/or radiation treatments
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor