Ovarian Tissue Transplantation

NCT ID: NCT01870752

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Infertile Females or Females With Ovarian Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transplantation of previously cryopreserved ovarian tissue

Surgical transplantation of previously collected cryopreserved ovarian cortical tissue.

Group Type OTHER

Transplantation of previously cryopreserved ovarian tissu

Intervention Type PROCEDURE

Interventions

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Transplantation of previously cryopreserved ovarian tissu

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clarisa R Gracia, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clarisa Gracia, MD

Role: CONTACT

877-204-9213

Facility Contacts

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Clarisa Gracia, MD

Role: primary

877-204-9213

Other Identifiers

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UPCC 02813

Identifier Type: -

Identifier Source: org_study_id

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