Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

NCT ID: NCT02846064

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Ovarian Function Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ovarian tissue cryopreservation

Group Type OTHER

Autograft of cryopreserved ovarian tissue

Intervention Type PROCEDURE

Orthotopic transplantation

Interventions

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Autograft of cryopreserved ovarian tissue

Orthotopic transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role collaborator

University Hospital, Marseille

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

CMCO SIHCUS, Schiltingheim

OTHER

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

Tenon Hospital, Paris

OTHER

Sponsor Role collaborator

Poissy-Saint Germain Hospital

OTHER

Sponsor Role collaborator

Hôpital Jean Verdier

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Hopital Antoine Beclere

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Besancon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Clotilde AMIOT, MD PhD

Role: CONTACT

+33381218681

Facility Contacts

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Clotilde AMIOT, PhD, MD

Role: primary

+33 3 81 21 86 81

References

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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.

Reference Type BACKGROUND
PMID: 20117783 (View on PubMed)

Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.

Reference Type BACKGROUND
PMID: 23633552 (View on PubMed)

Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.

Reference Type BACKGROUND
PMID: 17307173 (View on PubMed)

Pretalli JB, Frontczak Franck S, Pazart L, Roux C, Amiot C; DATOR Group. Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study. JMIR Res Protoc. 2019 Sep 30;8(9):e12944. doi: 10.2196/12944.

Reference Type BACKGROUND
PMID: 31573931 (View on PubMed)

Other Identifiers

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P/2012/143

Identifier Type: -

Identifier Source: org_study_id

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