Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft

Recruiting

• Conditions: Ovarian Function Insufficiency

• Registration Number: NCT02855827
• 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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.

Detailed Description

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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft. This cohort will be used to:

* Follow up of patients with their cryopreserved ovarian tissue;

* Evaluate requests for ovarian tissue grafting ;

* Propose a search of residual disease in case of neoplastic disease risk (if possible);

* Allowing patients to benefit from an ovarian tissue autograft;

* Assess the effectiveness of autograft technique after the restoration of ovarian function.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Patients who have cryopreserved their ovarian tissue;
• Patients with premature ovarian insufficiency;
• Patients older than 11 years (bone age) for induction of puberty;
• Patients aged from 18 to 43 years for the restoration of ovarian function;
• No objection from the patient
• Patients who have already received ovarian tissue autograft.

Exclusion Criteria

• Patients aged under 11 years (bone age);
• Patients older than 43 years;
• Patients refusing to be included;
• Patients (adults) under guardianship, curators and safeguard justice

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patient who are candidate to ovarian tissue autograft	5 years

Trial Locations

Locations (1)

CHRU Besancon; 🇫🇷 Besançon, France