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Improving Human Ovarian Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827476
First Posted: January 22, 2009
Last Update Posted: January 22, 2009
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. Read our disclaimer for details.
Collaborator:
Israel Science Foundation
Information provided by:
Hadassah Medical Organization
  Purpose
we will perform xenotransplantation and in vitro culture of ovarian tissue from patients undergoing ovarian cortex cryopreservation.

Condition Intervention Phase
Fertility Preservation Procedure: ovarian transplantation Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Improve Results of Human Ovarian Transplantation

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • improving folliculogenesis and oocuyte maturation after ovarian transplantation [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ovarian transplantation
tissue will be used for xenotransplantation or in vitro culture
Procedure: ovarian transplantation
ovarian xenotransplantation or in vitro culture

Detailed Description:
Ovarian tissue is removed by laparoscopy and only in patients facing premature ovarian failure due to chemotherapy.Tissue for research will consist either of a small portion (<10%) of the cortex for preservation for young women. another source of ovarian tissue for research will be obtained following consent from family of patients who have died of the disease and have previously frozen ovarian tissue.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tissue previously obtained

Exclusion Criteria:

  • no tissue available or no consent
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Ariel Revel, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00827476     History of Changes
Other Study ID Numbers: 0530-08-HMO- CTIL
First Submitted: January 21, 2009
First Posted: January 22, 2009
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by Hadassah Medical Organization:
ovary
human
transplantaion
ovarian failure