Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Function Insufficiency
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Restoration of ovarian function by using autograft
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who underwent Ovarian tissue cryopreservation
- •Premature ovarian failure
- •Patients cured of their primary disease
- •Women between 18 and 43 years of age
- •Patients who have already benefited from ovarian tissue autograft
Exclusion Criteria
- •Patients under trusteeship
- •Patients placed in receivers
- •Patients under the protection of a conservator
Outcomes
Primary Outcomes
Restoration of ovarian function by using autograft
Time Frame: 2 years
Secondary Outcomes
- Number of live births after ovarian tissue autograft(5 years)
- Number of graft recovery(5 years)
- Number of residual disease development.(5 years)
- Number of complications that could result from a surgery with anesthesia or depending on graft quality(5 years)