Improving Human Ovarian Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Israel Science Foundation
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00827476
First received: January 21, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   5 Years to 40 Years
Genders 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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ariel Revel, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00827476     History of Changes
Other Study ID Numbers: 0530-08-HMO- CTIL
Study First Received: January 21, 2009
Last Updated: January 21, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 22, 2014