Clinical trial NCT02855827: Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft
Official title: Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Function Insufficiency
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: CHU de Reims
name: University Hospital, Marseille
name: University Hospital, Lille
name: Central Hospital, Nancy, France
name: University Hospital, Grenoble
name: CMCO SIHCUS, Schiltingheim
name: University Hospital, Bordeaux
name: Nantes University Hospital
name: University Hospital, Limoges
First posted: 2016-08-04
Enrollment: 240
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 43
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients likely to re-use their ovarian tissue cryopreserved by autograft

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patient who are candidate to ovarian tissue autograft
timeFrame: 5 years
Secondary outcomes:
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.