Constitution of a Cohort for Monitoring Patients Candidat... | NCT02855827

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

NCT02855827

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Jul 12, 2024Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Ovarian Function Insufficiency

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013Actual

Primary Completion Date

Oct 2025Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

Jul 20, 2016

First Submission Date that Met QC Criteria

Aug 1, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2024

Last Update Posted Date

Jul 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

Collaborators

Name	Class
CHU de Reims	OTHER
University Hospital, Marseille	OTHER
University Hospital, Lille	OTHER
Central Hospital, Nancy, France

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

43 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chlotilde AMIOT, MD, PhD	Contact			camiot@chu-besancon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Besancon	Recruiting	Besançon		25030	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20117783	Background	Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.
23633552	Background