Ovarian Tissue Transplantation

Abramson Cancer Center at Penn Medicine10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertile Females or Females With Ovarian Insufficiency

Interventions

Transplantation of previously cryopreserved ovarian tissuPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Pregnancy

Time frame: 5 years

Return of menstrual function

Time frame: 5 years

Secondary Outcomes

Cancer recurrence

Time frame: 5 years

Surgical Complications of ovarian tissue transplantation

Including infection, hospital readmission, re-operation

Time frame: 5 years

Acceptability

Time frame: 5 years

Central Contacts

Clarisa Gracia, MD

CONTACT

877-204-9213 PennCancerTrials@emergingmed.com

Data from ClinicalTrials.gov

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