Ovarian Tissue Transplantation

September 4, 2025 updated by: Abramson Cancer Center at Penn Medicine

Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Abramson Cancer Center of The University of Pennsylvania
        • Contact:
          • Clarisa Gracia, MD
          • Phone Number: 877-204-9213
        • Principal Investigator:
          • Clarisa Gracia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patient between the ages of 18 and 45 years
  • Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
  • Ovarian insufficiency defined as an elevated FSH over 10
  • Inability to conceive after 6 months of unprotected intercourse with male
  • Reasonably good health
  • Candidate for pregnancy
  • Written clearance for the procedure from the patients oncologist

Exclusion Criteria:

  • Patients considered to be high risk for surgical complications will be excluded from the research protocol
  • Women who are known to be positive for the BRCA mutation
  • Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
  • Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
  • Current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transplantation of previously cryopreserved ovarian tissue
Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.
Procedure: Transplantation of previously cryopreserved ovarian tissu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy
Time Frame: 5 years
5 years
Return of menstrual function
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer recurrence
Time Frame: 5 years
5 years
Surgical Complications of ovarian tissue transplantation
Time Frame: 5 years
Including infection, hospital readmission, re-operation
5 years
Acceptability
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Clarisa R Gracia, MD, Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimated)

June 6, 2013

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 02813

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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