Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function (DATOR)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Ovarian Function Insufficiency

Treatments: Procedure: Autograft of cryopreserved ovarian tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT02846064

P/2012/143

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ovarian tissue cryopreservation

Other group

Treatment:

Procedure: Autograft of cryopreserved ovarian tissue