Validation of Donor Oocytes Semi-automated Vitrification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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 cost/effectiveness study will be carried out.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Egg donor
Oocyte puncture for donation
Good quality ovarian reserve (Antral follicle count evaluated by ultrasound: CFA ≥ 7)
Negative serology status (HIV, hepatitis B and C, syphilis, CMV and HTLV)
Disqualifiers
Decline to participate
Pregnant and lactating woman
Person under guardianship, curatorship, deprivation of liberty, protection of justice
Trial design
Design model
Parallel
Treatments tested in this trial
Gavi, Merck® (automated vitrification instrument)
DeviceThis instrument recently appeared on the market and demonstrated a high effectiveness in terms of processing time and reproducibility for embryo vitrification. To date, no study has analyzed the efficiency of this automated vitrification instrument on oocyte vitrification. The oocytes will be stored in closed cassettes in liquid nitrogen
Vitrolife system
DeviceThe oocytes vitrification will be carried out by an authorized technician according to the manual protocol validated and used routinely.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Manual vitrification (using Vitrolife system)Placebo comparator 1 intervention
Group B: Semi-automatic vitrification of oocytes using the GAVI® automaton (Merck)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oocyte survival
Oocyte survival after semi-automated vitrification by the GAVI® device compared to the manual technique (Vitrolife) with egg donation. A warmed oocyte that has survived can then be used in AMP by ICSI technique.
Time frame
two years after the inclusionSecondary outcomes
1
Effectiveness of ART with egg donation after oovcytes semi-automated vitrification
* oocyte functional quality after warming by assessing the fertilization rate for each oocyte * early development of embryos: number of embryos cleaved on the 2nd day of culture from vitrified oocytes, blastulation rate defined by the ratio between the number of blastocysts obtained (Gardner classification on the 5th day of culture) and total number of cleaved embryos. * implantation rate of embryos from vitrified oocytes, defined by the ratio between the number of embryonic sacs observed (6th week of amenorrhea) and the number of embryos transferred * rate of miscarriages in egg recipients
Time frame
two years after vitrification2
Study the costs and cost-effectiveness
Study the costs and cost-effectiveness of ART by egg donation, during semi-automatic oocyte vitrification and during manual technique, from a hospital point of view.
Time frame
at the end of the study 24 monthsSponsors and contacts
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Source ClinicalTrials.gov