Development of Ovarian Tissue Autograft in Order to Resto... | NCT02846064

Studies
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

NCT02846064

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Jul 12, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Ovarian Function Insufficiency

Interventions

Autograft of cryopreserved ovarian tissue

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

Oct 2013

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 25, 2013

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 27, 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
Nantes University Hospital	OTHER
University Hospital, Lille

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ovarian tissue cryopreservation	Other		Procedure: Autograft of cryopreserved ovarian tissue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autograft of cryopreserved ovarian tissue	Procedure	Orthotopic transplantation	Ovarian tissue cryopreservation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Restoration of ovarian function by using autograft		2 years

Secondary Outcomes

Measure	Description	Time Frame
Number of live births after ovarian tissue autograft		5 years
Number of complications that could result from a surgery with anesthesia or depending on graft quality		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clotilde AMIOT, MD PhD	Contact	+33381218681		clotilde.amiot@univ-fcomte.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