Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238570
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-02-16
Brief Title:
Validation of Donor Oocytes Semi-automated Vitrification
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Validation of Semi-automatic Oocyte Vitrification by the GAVI Machine in Medically Assisted Reproduction With Oocyte Donation
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAVIDO
Brief Summary:
Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011 The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing a method previously applied Oocytes reheated after vitrification show excellent results in terms of vitality and recovery of cellular functionality Indeed the fertilization rates observed after using warmed and fertilized oocytes in Assisted Reproduction Technology ART by intracytoplasmic sperm injection ICSI are similar to those obtained with fresh oocytes
However the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified
Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes However manual vitrification requires a learning curve is technician-dependent and requires significant technical time
A semi-automatic vitrification device GAVI Merck which recently appeared on the market has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART To our knowledge no study has analyzed the effectiveness of semi-automatic vitrification GAVI Merck on survival and oocyte quality after warming It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification
The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device Gavi of oocytes with regard to the oocyte survival rate compared to the manual technique used in ART
The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique in terms of ART results by comparing the fertilization rates the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation A costeffectiveness study will be carried out
However the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified
Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes However manual vitrification requires a learning curve is technician-dependent and requires significant technical time
A semi-automatic vitrification device GAVI Merck which recently appeared on the market has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART To our knowledge no study has analyzed the effectiveness of semi-automatic vitrification GAVI Merck on survival and oocyte quality after warming It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification
The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device Gavi of oocytes with regard to the oocyte survival rate compared to the manual technique used in ART
The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique in terms of ART results by comparing the fertilization rates the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation A costeffectiveness study will be carried out
Detailed Description:
The oocytes will be stored in closed devices Rapid I straws for the manual vitrification protocol or pods in cassettes for the semi-automatic vitrification protocol in liquid nitrogen All samples are anonymized in the context of oocyte donation by the medically assisted procreation PMA department of Clermont-Ferrand University Hospital according to the method usually used
The oocyte survival rate will be evaluated by the service technician or biologist This survival rate corresponds to the ratio between the number of oocytes intact 2 hours after warming and able to be microinjected with a spermatozoon ICSI and the number of oocytes heated after vitrification We will compare the oocyte survival rate after vitrification and semi-automatic warming vs after manual vitrification
The investigator will compare the effectiveness of ART with oocyte donation during semi-automatic vitrification of oocytes compared to the manual technique with regard to
Oocyte functional quality after warming evaluated by the fertilization rate of oocytes after ICSI
Early development of embryos
the number of embryos cleaved on the 2nd day of culture from vitrified oocytes the blastulation rate defined by the ratio between the number of blastocysts obtained Gardner classification on the 5th day of culture and the total number of cleaved embryos
These parameters will be assessed daily during the embryo reading by a technician or a biologist from the ART department
We will also compare the effectiveness of ART with oocyte donation during the semi-automatic vitrification of oocytes compared to the manual technique with regard to
The implantation rate of embryos from vitrified oocytes defined by the ratio between the number of embryo sacs observed 6th week of amenorrhea and the number of embryos transferred
The rate of miscarriages in oocyte recipients These parameters will be evaluated by a biologist from the ART department after the results of the beta hCG of the patients and the performance of the ultrasound at the 6th week of amenorrhea by the gynecologists of the ART department
The oocyte survival rate will be evaluated by the service technician or biologist This survival rate corresponds to the ratio between the number of oocytes intact 2 hours after warming and able to be microinjected with a spermatozoon ICSI and the number of oocytes heated after vitrification We will compare the oocyte survival rate after vitrification and semi-automatic warming vs after manual vitrification
The investigator will compare the effectiveness of ART with oocyte donation during semi-automatic vitrification of oocytes compared to the manual technique with regard to
Oocyte functional quality after warming evaluated by the fertilization rate of oocytes after ICSI
Early development of embryos
the number of embryos cleaved on the 2nd day of culture from vitrified oocytes the blastulation rate defined by the ratio between the number of blastocysts obtained Gardner classification on the 5th day of culture and the total number of cleaved embryos
These parameters will be assessed daily during the embryo reading by a technician or a biologist from the ART department
We will also compare the effectiveness of ART with oocyte donation during the semi-automatic vitrification of oocytes compared to the manual technique with regard to
The implantation rate of embryos from vitrified oocytes defined by the ratio between the number of embryo sacs observed 6th week of amenorrhea and the number of embryos transferred
The rate of miscarriages in oocyte recipients These parameters will be evaluated by a biologist from the ART department after the results of the beta hCG of the patients and the performance of the ultrasound at the 6th week of amenorrhea by the gynecologists of the ART department
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None