Clinical trial NCT02846064: Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
Official title: Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Function Insufficiency
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: CHU de Reims
name: University Hospital, Marseille
name: Nantes University Hospital
name: University Hospital, Lille
name: Central Hospital, Nancy, France
name: University Hospital, Toulouse
name: University Hospital, Grenoble
name: University Hospital, Bordeaux
name: CMCO SIHCUS, Schiltingheim
name: University Hospital, Rouen
name: University Hospital, Limoges
name: University Hospital, Angers
name: Centre Hospitalier Universitaire de Nice
name: Tenon Hospital, Paris
name: Poissy-Saint Germain Hospital
name: Hôpital Jean Verdier
name: University Hospital, Clermont-Ferrand
name: Hopital Antoine Beclere
First posted: 2016-07-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Restoration of ovarian function by using autograft
timeFrame: 2 years
Secondary outcomes:
measure: Number of live births after ovarian tissue autograft
timeFrame: 5 years
measure: Number of complications that could result from a surgery with anesthesia or depending on graft quality
timeFrame: 5 years
measure: Number of graft recovery
timeFrame: 5 years
measure: Number of residual disease development.
timeFrame: 5 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Besancon
Study officials:
References:
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.
citation: 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.
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. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.
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.