Clinical trial NCT06497998: EGG Sensor for Oocyte Characterization
Official title: Use of the EGG Sensor to Characterize Human Oocytes in IVF With ICSI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences in the global elasticity of the oocyte depending on whether or not it results in a live birth.
timeFrame: 36 months
measure: Differences in the global viscosity behaviour of the oocyte depending on whether or not it results in a live birth
timeFrame: 36 months
measure: Differences in the local elasticity of the oocyte depending on whether or not it results in a live birth
timeFrame: 36 months
measure: Differences in the local viscosity of the pellucid membrane depending on whether or not it results in a live birth
timeFrame: 36 months
Secondary outcomes:
measure: Differences in the mechanical characterization of an oocyte depending on whether or not it results in an early or late miscarriage.
timeFrame: 36 months
measure: Differences in the mechanical characterization of an oocyte depending on whether or not it results in a clinical pregnancy.
timeFrame: 36 months
measure: Differences in the mechanical characterization of an oocyte depending on whether or not it results in a biochemical pregnancy.
timeFrame: 36 months
measure: Morphological characterization of mature oocytes (included in the ICSI procedure) and of abnormal or immature oocytes (excluded from the ICSI procedure).
timeFrame: On the day the IVF with ICSI is performed
measure: Mechanical characterization of abnormal or immature oocytes (excluded from the ICSI procedure) from the same cohort.
timeFrame: On the day the IVF with ICSI is performed
measure: Associations between oocytes' mechanical characteristics and patients' clinical and demographic characteristics.
timeFrame: 36 months
measure: Biochemical pregnancy rates
timeFrame: 36 months
measure: Early and late miscarriages rates
timeFrame: 36 months
measure: Clinical pregnancy rates
timeFrame: 36 months
measure: Live births rates
timeFrame: 36 months
Other outcomes:
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