Ovarian Tissue Transplantation

Not Applicable

Recruiting

• Conditions: Infertile Females or Females With Ovarian Insufficiency
• Interventions: Procedure: Transplantation of previously cryopreserved ovarian tissu

• Registration Number: NCT01870752
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2028-06
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transplantation of previously cryopreserved ovarian tissue	Transplantation of previously cryopreserved ovarian tissu	Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Primary Outcome Measures

Name	Time	Method
Pregnancy	5 years
Return of menstrual function	5 years

Secondary Outcome Measures

Name	Time	Method
Surgical Complications of ovarian tissue transplantation	5 years	Including infection, hospital readmission, re-operation
Cancer recurrence	5 years
Acceptability	5 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States