An interventional study of Mechanical characterization in Infertility, sponsored by Centre Hospitalier Universitaire de Besancon. Not yet recruiting. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other
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.
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 449 studies on the registry; 98 are open to participants now.
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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.
Device: Mechanical characterization
Usual ICSI procedures
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.
Differences in the global elasticity of the oocyte depending on whether or not it results in a live birth.
Global elasticity obtained from a loading and unloading test at constant speed using a large flat shape to compress it. The output is a curve related to the force applied to the oocyte versus the indentation depth. This curve is representative of the global oocyte elasticity.
Time frame: 36 months
Differences in the global viscosity behaviour of the oocyte depending on whether or not it results in a live birth
Global viscosity behaviour obtained from a loading test at constant speed followed by keeping the indentation depth. In this test, we are also using the large flat shape of indenter tip.The output is a curve related to the force applied to the oocyte versus time that quantify the global relaxation phenomenon of the oocyte.
Time frame: 36 months
Differences in the local elasticity of the oocyte depending on whether or not it results in a live birth
Local elasticity obtained from a loading and unloading test at constant speed using a sharp shape in order to specifically characterize pellucid membrane. The output is a curve related to the force applied to the oocyte versus the indentation depth. This curve is representative of the pellucide membrane elasticity.
Time frame: 36 months
Differences in the local viscosity of the pellucid membrane depending on whether or not it results in a live birth
Local viscosity behaviour of the pellucid membrane obtained from a loading test at constant speed followed by keeping the indentation depth. In this test, we are also using the sharp shape of indenter tip.The output is a curve related to the force applied to the oocyte versus time that mainly quantify the local relaxation phenomenon of the pellucid membrane.
Time frame: 36 months
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.
Patients' clinical and demographic data include age, medical history (smoking, fertility status), the number of obtained oocytes..
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
No study locations are listed for this record.
Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Informed consent form
Time frame: Immediately following publication. No end date
Access criteria: Researchers who submit a methodologically sound proposal approved by our research team
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Sep 2027, 36 months later.
Of 498 non-industry interventional studies with no phase under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 36 months is above that.
Counting every sponsor, half of 541 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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