Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Not Applicable

Recruiting

• Conditions: Ovarian Function Insufficiency
• Interventions: Procedure: Autograft of cryopreserved ovarian tissue

• Registration Number: NCT02846064
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Primary Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian tissue cryopreservation	Autograft of cryopreserved ovarian tissue	-

Primary Outcome Measures

Name	Time	Method
Restoration of ovarian function by using autograft	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHRU Besancon; 🇫🇷 Besançon, France