Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06238570
Other study ID # AOI 2020 CHAPUT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 23, 2024
Est. completion date June 2025

Study information

Verified date June 2023
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 cost/effectiveness study will be carried out.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria: - 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) - Absence of symptoms or COVID contact - Absence of genetic contraindication to egg donation - Woman able to give informed consent to participate in research - Woman affiliated to a social security scheme Exclusion Criteria: - Decline to participate - Pregnant and lactating woman - Person under guardianship, curatorship, deprivation of liberty, protection of justice

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Gavi, Merck® (automated vitrification instrument)
This 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
The oocytes vitrification will be carried out by an authorized technician according to the manual protocol validated and used routinely.

Locations

Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. two years after the inclusion
Secondary 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
two years after vitrification
Secondary 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. at the end of the study 24 months
See also
  Status Clinical Trial Phase
Withdrawn NCT02759705 - Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
Not yet recruiting NCT02534857 - A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment N/A
Enrolling by invitation NCT01803893 - Prognostic Value of PIF Detection in Embryo Culture Media Correlation With Pregnancy Outcome N/A
Completed NCT01888744 - Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist Phase 4
Terminated NCT01173276 - Intrauterine Insemination In HIV-Discordant Couples N/A
Not yet recruiting NCT03680937 - Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes
Completed NCT03455062 - Fertility Study of Women Who Received Organ Transplantation N/A
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Completed NCT01895192 - Sperm Morphology by High Magnification in Fertility Men N/A
Terminated NCT01614704 - Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Terminated NCT01232972 - Oocyte Cryopreservation N/A
Terminated NCT01268592 - Fertility Preservation in Female Cancer Patients N/A
Completed NCT01012596 - Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
Completed NCT00390754 - Usefulness of Home Pregnancy Testing N/A
Completed NCT00231504 - Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count Phase 1
Completed NCT03345264 - The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study N/A
Recruiting NCT05414812 - Intervening on Women's Health for Rural Young Breast Cancer Survivors N/A
Active, not recruiting NCT02661932 - Fertility Preservation in Breast Cancer Patients Phase 4
Recruiting NCT06172504 - Ejaculation Frequency and Semen Parameters
Recruiting NCT02878434 - Fertility Preservation in Young Women With Cancer