Ovarian Tissue Transplantation

NCT01870752 | Recruiting

• 1 other identifier: UPCC 02813
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertile Females or Females With Ovarian Insufficiency

Outcome Measures

Primary Outcomes (2)

• Pregnancy

  5 years

• Return of menstrual function

  5 years

Secondary Outcomes (3)

• Cancer recurrence

  5 years

• Surgical Complications of ovarian tissue transplantation

  5 years

• Acceptability

  5 years

Study Arms (1)

Transplantation of previously cryopreserved ovarian tissue

OTHER

Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Procedure: Transplantation of previously cryopreserved ovarian tissu

Interventions

Transplantation of previously cryopreserved ovarian tissu PROCEDURE

Transplantation of previously cryopreserved ovarian tissue

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Clarisa R Gracia, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarisa Gracia, MD

CONTACT

877-204-9213; PennCancerTrials@emergingmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)