Ovarian Tissue Transplantation | NCT01870752

Studies
Ovarian Tissue Transplantation

NCT01870752

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Infertile Females or Females With Ovarian Insufficiency

Interventions

Transplantation of previously cryopreserved ovarian tissu

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Jun 4, 2013

First Submission Date that Met QC Criteria

Jun 4, 2013

First Posted Date

Jun 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2025

Last Update Posted Date

Sep 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transplantation of previously cryopreserved ovarian tissue	Other	Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.	Procedure: Transplantation of previously cryopreserved ovarian tissu

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transplantation of previously cryopreserved ovarian tissu	Procedure		Transplantation of previously cryopreserved ovarian tissue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy		5 years
Return of menstrual function		5 years

Secondary Outcomes

Measure	Description	Time Frame
Cancer recurrence		5 years
Surgical Complications of ovarian tissue transplantation	Including infection, hospital readmission, re-operation	5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clarisa Gracia, MD	Contact	877-204-9213		PennCancerTrials@emergingmed.com

Overall Officials

Name	Affiliation	Role
Clarisa R Gracia, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania	Recruiting	Philadelphia	Pennsylvania	19104	United States