Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation (GAVI)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The last decade has seen a development of a new cryopreservation technique called vitrification. Despite a lack of randomized control trials comparing slow-freezing and vitrification, vitrification seems to show better recovery rates and pregnancy outcomes. However vitrification is a manual, labour-intensive and highly skilled procedure, results can vary between embryologists and clinics. The GAVI system, an automation instrument with a novel closed system device has been developed. The present study would like to assess the outcomes for embryos automatically vitrification processed with the GAVI system compared with those processed with conventional reference technique of slow freezing.
The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies center of Toulouse.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Toulouse, France, 31059
- Hospital University of Toulouse
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Couple whose age is > 18 years and who are included in a IVF procedure with the possibility to cryopreserve embryos according to criteria applied at the hospital of Toulouse
- Signed informed consent by both partners in a couple
- Affiliation to a social security scheme for both partners of the couple
Exclusion Criteria:
- Couples who does not meet current requirements described by the bioethics law for accession to the ART procedure
- Positive plasma viral load for HIV, hepatitis C virus or hepatitis B virus during the year before the inclusion in one of the couple.
- One of the two partners (or both) is (are) in safeguarding justice, under guardianship or trusteeship.
- Couple included in another interventional study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: reference technique slow freezing
In reference technique slow freezing arm, embryon will be frozen with the conventional slow freezing procedure with the Freezal device apply a slow decreasing in temperature with moderate cryoprotector concentration
|
Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos.
Embryon are frozen with a slow freezing.
|
|
Expérimental: vitrification technique
In vitrification technique arm, embryon will be frozen with automated vitrification system
|
Vitrification is the new technique to freeze embryons.
In this study, the GAVI system will be use for for embryos automatically vitrification
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Implantation rate of frozen/thawed embryos
Délai: 1 month
|
The number of implantation embryo with cardiac activity in reference technique and in vitrification technic
|
1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of intact blastomeres after thawing
Délai: 1 month
|
It will be measured by microscopic evaluation by a biologist or an IVF laboratory technician at the time of thawing, routine very simple laboratory to do because at this early embryonic stage there are few cells: 4 to 8 cells and they are well individualized.
|
1 month
|
|
Implantation rate of transferred embryos.
Délai: 1 month
|
number of implantation of transferred embryos in both technique
|
1 month
|
|
Live birth rates
Délai: 9 months after the implantation
|
Number of live birth for reference technique and for vitrification technique
|
9 months after the implantation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Roger Léandri, MD, University Hospital, Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- RC31/16/8766
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .