Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft (PERIDATOR)

January 26, 2021 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 43 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients likely to re-use their ovarian tissue cryopreserved by autograft

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patient who are candidate to ovarian tissue autograft
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

CHU de Reims
Central Hospital, Nancy, France
University Hospital, Bordeaux
University Hospital, Limoges
University Hospital, Grenoble
University Hospital, Lille
Nantes University Hospital
University Hospital, Marseille
CMCO SIHCUS, Schiltingheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • P/2013/170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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