Ovarian Tissue Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01870752
First received: June 4, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01870752     History of Changes
Other Study ID Numbers: UPCC 02813
Study First Received: June 4, 2013
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Menopause, Premature
Primary Ovarian Insufficiency
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014