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Tracking Information | |
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First Received Date † | January 21, 2009 |
Last Updated Date | January 21, 2009 |
Start Date † | January 2009 |
Current Primary Outcome Measures † |
improving folliculogenesis and oocuyte maturation after ovarian transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Improving Human Ovarian Transplantation |
Official Title † | Phase 1 Study to Improve Results of Human Ovarian Transplantation |
Brief Summary | we will perform xenotransplantation and in vitro culture of ovarian tissue from patients undergoing ovarian cortex cryopreservation. |
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. |
Study Phase | Phase 0 |
Study Type † | Interventional |
Study Design † | Treatment, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Condition † | Fertility Preservation |
Intervention † | Procedure: ovarian transplantation |
Study Arms / Comparison Groups | Experimental: tissue will be used for xenotransplantation or in vitro culture |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Active, not recruiting |
Estimated Enrollment † | 100 |
Estimated Completion Date | January 2015 |
Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female |
Ages | 5 Years to 40 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00827476 |
Responsible Party | Ariel Revel, Hadassah Medical Organization |
Secondary IDs †† | |
Study Sponsor † | Hadassah Medical Organization |
Collaborators †† | Israel Science Foundation |
Investigators † | |
Information Provided By | Hadassah Medical Organization |
Verification Date | January 2009 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |