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EGG Sensor for Oocyte Characterization

No phase Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mechanical characterization.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 43 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Use of the EGG Sensor to Characterize Human Oocytes in IVF With ICSI

Overview

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.

Interventions

  • Device 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 preve

Primary outcome measures

  • Differences in the global elasticity of the oocyte depending on whether or not it results in a live birth. [Time frame: 36 months]
  • Differences in the global viscosity behaviour of the oocyte depending on whether or not it results in a live birth [Time frame: 36 months]
  • Differences in the local elasticity of the oocyte depending on whether or not it results in a live birth [Time frame: 36 months]
  • Differences in the local viscosity of the pellucid membrane depending on whether or not it results in a live birth [Time frame: 36 months]
Secondary outcome measures (10)
  • Differences in the mechanical characterization of an oocyte depending on whether or not it results in an early or late miscarriage. [Time frame: 36 months]
  • Differences in the mechanical characterization of an oocyte depending on whether or not it results in a clinical pregnancy. [Time frame: 36 months]
  • Differences in the mechanical characterization of an oocyte depending on whether or not it results in a biochemical pregnancy. [Time frame: 36 months]
  • Morphological characterization of mature oocytes (included in the ICSI procedure) and of abnormal or immature oocytes (excluded from the ICSI procedure). [Time frame: On the day the IVF with ICSI is performed]
  • Mechanical characterization of abnormal or immature oocytes (excluded from the ICSI procedure) from the same cohort. [Time frame: On the day the IVF with ICSI is performed]
  • Associations between oocytes' mechanical characteristics and patients' clinical and demographic characteristics. [Time frame: 36 months]
  • Biochemical pregnancy rates [Time frame: 36 months]
  • Early and late miscarriages rates [Time frame: 36 months]
  • Clinical pregnancy rates [Time frame: 36 months]
  • Live births rates [Time frame: 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06497998 · 2023/776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗