Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-30
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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EGG sensor
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.
Mechanical characterization
The oocyte is placed in a culture dish with IVF culture medium. This procedure is similar to that used in the ICSI procedure, except that the injection pipette is replaced by a glass indenter. The indenter (sterile, single-use, blunt-edged glass cylinder, L:16mm, ø:0.85mm, mass:8mg) is completely decoupled from the micromanipulation and microinjection platform and driven by the principle of a magnetic spring with negative stiffness.
The oocyte is immobilized using a restraining pipette to prevent unwanted movement during measurement.
The main objective is to investigate the prognostic value of parameters derived from kinetic measurements of microforces on mature human oocytes in the context of IVF with ICSI.
On each oocyte the mechanical testing is divided in 4 successive loading unloading phase to measure:
* global elasticity of the oocyte.
* global viscosity behaviour of the oocyte.
* local elasticity of the oocyte.
* local viscosity behaviour of the pellucid membrane.
Standard
Usual ICSI procedures
No interventions assigned to this group
Interventions
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Mechanical characterization
The oocyte is placed in a culture dish with IVF culture medium. This procedure is similar to that used in the ICSI procedure, except that the injection pipette is replaced by a glass indenter. The indenter (sterile, single-use, blunt-edged glass cylinder, L:16mm, ø:0.85mm, mass:8mg) is completely decoupled from the micromanipulation and microinjection platform and driven by the principle of a magnetic spring with negative stiffness.
The oocyte is immobilized using a restraining pipette to prevent unwanted movement during measurement.
The main objective is to investigate the prognostic value of parameters derived from kinetic measurements of microforces on mature human oocytes in the context of IVF with ICSI.
On each oocyte the mechanical testing is divided in 4 successive loading unloading phase to measure:
* global elasticity of the oocyte.
* global viscosity behaviour of the oocyte.
* local elasticity of the oocyte.
* local viscosity behaviour of the pellucid membrane.
Eligibility Criteria
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Inclusion Criteria
* 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 \> 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
18 Years
43 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2023/776
Identifier Type: -
Identifier Source: org_study_id
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