Improving Human Ovarian Transplantation

This study is ongoing, but not recruiting participants.

First Received: January 21, 2009 No Changes Posted

Sponsors and Collaborators:	Hadassah Medical Organization Israel Science Foundation
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00827476

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
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
ovarian transplantation: Experimental 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

No Contacts or Locations Provided

More Information

No publications provided

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

Keywords provided by Hadassah Medical Organization:

ovary
human
transplantaion
ovarian failure

Study placed in the following topic categories:

Infertility
Ovarian Failure, Premature

ClinicalTrials.gov processed this record on May 06, 2009