EGG Sensor for Oocyte Characterization (EGG_SENSOR)

Centre Hospitalier Universitaire de Besancon

Status: Not yet enrolling

Conditions: Infertility

Treatments: Device: Mechanical characterization

Study type: Interventional

Funder types: Other

Identifiers

NCT06497998

2023/776

Details and patient eligibility

About

While intracytoplasmic sperm injection (ICSI) has made significant progress in the treatment of male infertility, the cumulative delivery rate is less than 30%, and birth is sometimes only achieved after several transfers. This success rate, combined with the possibility of repeated transfer failures, causes great distress, impacting couples' personal, social, and professional lives. These failures also have a significant economic impact on society and assisted reproductive technologies (ART) laboratories, including costs related to personnel, consumables, and cryopreservation activities.

Among the factors influencing the success of ICSI, the quality of the oocyte is paramount. Identifying mature oocytes with high birth potential is therefore a crucial step in any attempt.

At present, oocyte selection is mainly based on subjective visual morphological criteria, primarily limited to the stage of meiotic maturation. Various objective selection criteria are currently being tested, such as markers in follicular fluid or the transcriptome of cumulus and granulosa cells.

Mechanical oocyte characterization is another objective approach to assessing oocyte quality. EGG Sensor is a reliable, cost-effective platform that measures forces ranging from a few nanonewtons to a few micronewtons in a liquid medium on living cells. It enables the characterization of the mechanical behavior of oocytes (kinetic measurements of forces resulting from EGG sensor action).

The EGG sensor has been evaluated, enabling the EGG platform to be duplicated at the ART center of the Besançon University Hospital, making measurement and calibration more reliable, and allowing for the characterization of a series of oocytes excluded from the ICSI procedure.

The preclinical stages in the development of the EGG sensor have thus been validated. The next stage of development is to validate the device in an operational environment. The aim of this pilot study is to evaluate the mechanical qualification of oocytes by the EGG sensor in real-life conditions during an ICSI-type ART attempt.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women between 18 and 43 years old.
• Candidates for in vitro fertilization with ICSI treatment
• Male infertility (with the exception of testicular sperm extraction (TESA or MESA), donation of sperm and oocytes).
• Normal mobility and morphology of sperm selected for ICSI.
• Agreement given by the multidisciplinary team of the ART center (patients considered to have a "good prognosis" at the conclusion of the meeting, with normal ovarian reserve (follicular count between 15 and 25), and candidates for single embryo transfer.
• Consenting to the EGG sensor examination of 50% of mature oocytes collected.
• Signed informed consent.
• Affiliated to the French social security system (including CMU).

Exclusion criteria

• age < 18 years
• age > 43 years
• Infertility of female origin (severe endometriosis, genetic origin, uterine malformations that may interfere with implantation, etc.).
• Opposition of the multidisciplinary team of the ART center and/or patients with poor or average prognosis at the conclusion of the multidisciplinary ART meeting.
• Person under legal protection and/or unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
• Subject without health insurance
• Subject is in the exclusion period of another study or listed in the "volunteers' registry

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

EGG sensor

Experimental group

Description:

Mechanical characterization is performed using a glass indenter that applies a load to the oocyte. The indenter is a sterile, single-use, blunt-edged glass cylinder with a flat support end featuring a small foam formation, approximately the diameter of a micropipette. Except for the mechanical characterization, all oocytes are managed similarly according to validated procedures: in the same location, under the same metrological constraints (temperature and pH (potential of hydrogen) monitoring), and are handled by the same competent ART personnel.

Treatment:

Device: Mechanical characterization

Standard

No Intervention group

Description:

Usual ICSI procedures