Actively Recruiting
Autologous Ovarian Tissue Transplantation for Female Infertility After Chemotherapy or Radiation
Led by University of Pittsburgh · Updated on 2025-08-14
5
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the safety and effectiveness of using a woman's own previously frozen ovarian tissue to help restore fertility in females diagnosed with primary ovarian insufficiency after chemotherapy and/or radiation treatments. The study is designed to evaluate how well ovarian tissue transplantation can improve reproductive hormone levels and support pregnancy in women who have experienced infertility due to cancer treatments. The treatment involves thawing and surgically transplanting ovarian cortical tissue that was previously frozen. This is done through minimally invasive surgery such as laparoscopy or a small abdominal incision if laparoscopy is not suitable. After transplantation, patients will have scheduled follow-up visits to monitor their recovery, hormone levels, menstrual function, and possible pregnancy outcomes. The study also includes an annual survey starting three years after transplantation to gather longer-term information. Participants will undergo a screening visit with fertility tests, hormone measurements, ultrasound exams, and counseling, including clearance from their oncologist. After transplantation, follow-up visits occur at 1.5, 3, 6, 9, 12, and 24 months to assess reproductive health and quality of life using hormone tests, ultrasounds, and validated surveys. Safety monitoring includes checking for surgical complications and possible cancer recurrence. The study may continue tracking participants for up to 15 years with yearly surveys to record menstrual cycles, pregnancy, and health status.
CONDITIONS
Brief Title
Autologous Ovarian Tissue Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously cryopreserved ovarian tissue
- Diagnosis of ovarian insufficiency and/or candidate for pregnancy
- Good overall health
- Clearance from oncologist to participate
You will not qualify if you...
- High risk for surgical complications
- Contraindication for pregnancy if pregnancy is a goal
- Positive for BRCA gene mutations
- History of leukemia, ovarian cancer, or cancer involving ovaries at tissue collection
- Psychological or psychiatric conditions preventing informed consent
- Current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure with immediate recovery period
Participants undergo ovarian tissue thawing and transplantation via outpatient laparoscopy or minilaparotomy under general anesthesia.
1 pre-operative visit and 1 transplantation visit (in-person)
Duration - Up to 24 months post-transplant
Participants have a series of assessments during the first two years after transplantation to monitor reproductive hormone levels, menstrual function, surgical complications, pregnancy status, and emotional well-being.
Approximately 7 visits: 1 post-operative visit within 6 weeks and 5 follow-up visits at 3, 6, 9, 12, and 24 months post-op, plus additional visits if menstruation is restored between scheduled visits (all in-person)
Duration - Annual surveys beginning year 3 post-transplant
Participants are surveyed annually starting 3 years after transplantation to track menstrual and pregnancy history, new diagnoses or treatments, and study participation experience.
Annual surveys via phone or secure email
Trial Site Locations
Total: 1 location
1
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
Jennifer Anglin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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