EGG Sensor for Oocyte Characterization

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Differences in the global elasticity of the oocyte depending on whether or not it results in a live birth. [Срок оценки: 36 months]
• Differences in the global viscosity behaviour of the oocyte depending on whether or not it results in a live birth [Срок оценки: 36 months]
• Differences in the local elasticity of the oocyte depending on whether or not it results in a live birth [Срок оценки: 36 months]
• Differences in the local viscosity of the pellucid membrane depending on whether or not it results in a live birth [Срок оценки: 36 months]

Вторичные конечные точки (10)

• Differences in the mechanical characterization of an oocyte depending on whether or not it results in an early or late miscarriage. [Срок оценки: 36 months]
• Differences in the mechanical characterization of an oocyte depending on whether or not it results in a clinical pregnancy. [Срок оценки: 36 months]
• Differences in the mechanical characterization of an oocyte depending on whether or not it results in a biochemical pregnancy. [Срок оценки: 36 months]
• Morphological characterization of mature oocytes (included in the ICSI procedure) and of abnormal or immature oocytes (excluded from the ICSI procedure). [Срок оценки: 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. [Срок оценки: On the day the IVF with ICSI is performed]
• Associations between oocytes' mechanical characteristics and patients' clinical and demographic characteristics. [Срок оценки: 36 months]
• Biochemical pregnancy rates [Срок оценки: 36 months]
• Early and late miscarriages rates [Срок оценки: 36 months]
• Clinical pregnancy rates [Срок оценки: 36 months]
• Live births rates [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06497998 · 2023/776

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗