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

Ovarian Function Insufficiency Clinical Trial

— PERIDATOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855827
• Other study ID #: P/2013/170
• Status: Recruiting
• Start date: May 2013
• Est. completion date: October 2022

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Chlotilde AMIOT, MD, PhD
• Email: camiot[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Function Insufficiency

Locations

Country	Name	City	State
France	CHRU Besancon	Besançon

Sponsors (10)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Central Hospital, Nancy, France, CHU de Reims, CMCO SIHCUS, Schiltingheim, Nantes University Hospital, University Hospital, Bordeaux, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, University Hospital, Marseille

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. Epub 2007 Feb 20. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient who are candidate to ovarian tissue autograft		5 years