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Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02846064
Acronym
DATOR
Enrollment
50
Registered
2016-07-27
Start date
2013-10-31
Completion date
2024-12-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Function Insufficiency

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.

Interventions

PROCEDUREAutograft of cryopreserved ovarian tissue

Orthotopic transplantation

Sponsors

CHU de Reims
CollaboratorOTHER
University Hospital, Marseille
CollaboratorOTHER
Nantes University Hospital
CollaboratorOTHER
University Hospital, Lille
CollaboratorOTHER
Central Hospital, Nancy, France
CollaboratorOTHER
University Hospital, Toulouse
CollaboratorOTHER
University Hospital, Grenoble
CollaboratorOTHER
University Hospital, Bordeaux
CollaboratorOTHER
CMCO SIHCUS, Schiltingheim
CollaboratorOTHER
University Hospital, Rouen
CollaboratorOTHER
University Hospital, Limoges
CollaboratorOTHER
University Hospital, Angers
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Nice
CollaboratorOTHER
Tenon Hospital, Paris
CollaboratorOTHER
Poissy-Saint Germain Hospital
CollaboratorOTHER
Hôpital Jean Verdier
CollaboratorOTHER
University Hospital, Clermont-Ferrand
CollaboratorOTHER
Hopital Antoine Beclere
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Restoration of ovarian function by using autograft2 years

Secondary

MeasureTime frame
Number of live births after ovarian tissue autograft5 years
Number of complications that could result from a surgery with anesthesia or depending on graft quality5 years
Number of graft recovery5 years
Number of residual disease development.5 years

Countries

France

Contacts

Primary ContactClotilde AMIOT, MD PhD
clotilde.amiot@univ-fcomte.fr+33381218681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026