Back to results

Ovarian Tissue Transplantation

Primary Purpose

Infertile Females or Females With Ovarian Insufficiency

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transplantation of previously cryopreserved ovarian tissu

About this trial

This is an interventional treatment trial for Infertile Females or Females With Ovarian Insufficiency

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Abramson Cancer Center of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Transplantation of previously cryopreserved ovarian tissue

Arm Description

Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Outcomes

Primary Outcome Measures

Pregnancy

Return of menstrual function

Secondary Outcome Measures

Cancer recurrence

Surgical Complications of ovarian tissue transplantation

Including infection, hospital readmission, re-operation

Acceptability

Full Information

NCT ID

NCT01870752

First Posted

June 4, 2013

Last Updated

July 18, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01870752

Brief Title

Ovarian Tissue Transplantation

Official Title

Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 2013 (undefined)

Primary Completion Date

June 2028 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertile Females or Females With Ovarian Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transplantation of previously cryopreserved ovarian tissue

Arm Type

Other

Arm Description

Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Intervention Type

Procedure

Intervention Name(s)

Transplantation of previously cryopreserved ovarian tissu

Primary Outcome Measure Information:

Title

Pregnancy

Time Frame

5 years

Title

Return of menstrual function

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Cancer recurrence

Time Frame

5 years

Title

Surgical Complications of ovarian tissue transplantation

Description

Including infection, hospital readmission, re-operation

Time Frame

5 years

Title

Acceptability

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clarisa Gracia, MD

Phone

877-204-9213

PennCancerTrials@emergingmed.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clarisa R Gracia, MD

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clarisa Gracia, MD

Phone

877-204-9213

First Name & Middle Initial & Last Name & Degree

Clarisa Gracia, MD

12. IPD Sharing Statement

Learn more about this trial

Ovarian Tissue Transplantation

We'll reach out to this number within 24 hrs