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Ovarian Tissue Transplantation

This study is currently recruiting participants.
Verified September 2016 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01870752
First Posted: June 6, 2013
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention
Infertile Females or Females With Ovarian Insufficiency Radiation: Chemotherapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 2 years ]

Estimated Enrollment: 10
Study Start Date: June 2013
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870752


Contacts
Contact: Clarisa Gracia, MD 877-204-9213 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Clarisa Gracia, MD    877-204-9213      
Principal Investigator: Clarisa Gracia, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Clarisa R Gracia, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01870752     History of Changes
Other Study ID Numbers: UPCC 02813
First Submitted: June 4, 2013
First Posted: June 6, 2013
Last Update Posted: September 26, 2016
Last Verified: September 2016