Ovarian Tissue Transplant for Infertility

This study is exploring a procedure called ovarian tissue transplant to help women who have become infertile due to cancer treatments like chemotherapy or radiation. The procedure involves taking pieces of your previously frozen ovarian tissue and placing them back into your abdomen. Researchers want to see if this transplant can restore your hormone levels, bring back regular menstrual cycles, and lead to a successful pregnancy and live birth. You might be able to join if you are a woman between 18 and 45 years old, have previously frozen ovarian tissue, and are in good health. However, you cannot participate if you have certain health risks, a BRCA mutation (a specific gene change), or a history of leukemia. The current status of this study is unclear, and it plans to enroll 5 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 5 women.
What's involved
You would have a screening visit including a medical history, fertility tests, and an ultrasound. After the transplant, you would have follow-up assessments for 2 years, then an annual survey.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for changes in hormone levels for 24 months, and for return of menstrual cycles and successful pregnancy for up to 15 years.

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NCT03496636

Autologous Ovarian Tissue Transplantation

Recruiting
NAAges 18–45InterventionalTreatment
University of Pittsburgh
~5 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Ovarian tissue transplant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in reproductive hormone levels after ovarian tissue transplant
Measured over 1,3,6,9,12 and 24 months post-transplantation
+2 more outcomes measured
Female Infertility
1 sites across 1 states
Pennsylvania1
  • Kyle Orwig, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh/University of Pittsburgh Medical Center

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Eligibility criteria

Inclusion

Previously cryopreserved ovarian tissue
Ovarian insufficiency and/or candidate for pregnancy
Good health
Oncologist's clearance

Exclusion

Patients considered to be high risk for surgical complications
Women with contraindication for pregnancy if goal is to achieve pregnancy
Women positive for the BRCA mutations
Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection
Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
Current pregnancy
  • Change in reproductive hormone levels after ovarian tissue transplant1,3,6,9,12 and 24 months post-transplantation

    Measure of reproductive hormone levels (FSH, AMH, LH E2 and others) to detect graft function

  • Return of regular monthly menstrual cyclesThrough study completion, up to 15 years

    Onset of regular monthly menstrual cycles after transplantation would indicate graft function. This needs to be analyzed at multiple time points to assess if regular monthly menstrual cycles have ceased, which could indicate graft failure.

  • Achievement of successful pregnancy, measured by live birthThrough study completion, up to 15 years

    Indicates recovery of ovarian function