RECRUITING

Ovarian Tissue Transplantation

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Conditions

Infertile Females or Females With Ovarian Insufficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Quick Facts

Study Start:2013-06
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01870752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patient between the ages of 18 and 45 years
  2. * Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
  3. * Ovarian insufficiency defined as an elevated FSH over 10
  4. * Inability to conceive after 6 months of unprotected intercourse with male
  5. * Reasonably good health
  6. * Candidate for pregnancy
  7. * Written clearance for the procedure from the patients oncologist
  1. * Patients considered to be high risk for surgical complications will be excluded from the research protocol
  2. * Women who are known to be positive for the BRCA mutation
  3. * Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
  4. * Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
  5. * Current pregnancy

Contacts and Locations

Study Contact

Clarisa Gracia, MD
CONTACT
877-204-9213
PennCancerTrials@emergingmed.com

Principal Investigator

Clarisa R Gracia, MD
PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine

Study Locations (Sites)

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Clarisa R Gracia, MD, PRINCIPAL_INVESTIGATOR, Abramson Cancer Center at Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-06
Study Completion Date2028-12

Study Record Updates

Study Start Date2013-06
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Infertile Females or Females With Ovarian Insufficiency