Recruiting

Ovarian Tissue Cryopreservation

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT01870752

Conditions

Infertile Females or Females With Ovarian Insufficiency

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Transplantation of previously cryopreserved ovarian tissu

Study Details

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

Study ID

NCT01870752

Start date

Jun, 2013

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Transplantation of previously cryopreserved ovarian tissue

Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Interventions

Transplantation of previously cryopreserved ovarian tissu

Primary outcome measure

  • Pregnancy [ Time Frame: 5 years ]
  • Return of menstrual function [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Clarisa Gracia, MD

877-204-9213PennCancerTrials@emergingmed.com

Locations

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Clarisa Gracia, MD

877-204-9213

Principal Investigator:

Clarisa Gracia, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2025-09-10.