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

NCT ID: NCT02855827

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

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2025-10-31

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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.

Detailed Description

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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 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.

Conditions

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Ovarian Function Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 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

University Hospital, Lille

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

CMCO SIHCUS, Schiltingheim

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Limoges

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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Chlotilde AMIOT, MD, PhD

Role: CONTACT

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)

Other Identifiers

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P/2013/170

Identifier Type: -

Identifier Source: org_study_id

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