Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Ovarian Function Insufficiency Clinical Trial

— DATOR  

Official title:

Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02846064
• Other study ID #: P/2012/143
• Status: Recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2022

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Clotilde AMIOT, MD PhD
• Phone: +33381218681
• Email: clotilde.amiot[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Interventional

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Function Insufficiency

Intervention

Procedure:
• Autograft of cryopreserved ovarian tissue
Orthotopic transplantation

Locations

Country	Name	City	State
France	CHRU Besancon	Besançon

Sponsors (12)

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, University Hospital, Rouen, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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

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. — 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	Restoration of ovarian function by using autograft		2 years
Secondary	Number of live births after ovarian tissue autograft		5 years
Secondary	Number of complications that could result from a surgery with anesthesia or depending on graft quality		5 years
Secondary	Number of graft recovery		5 years
Secondary	Number of residual disease development.		5 years