InfertilityEGG_SENSORNCT06497998
EGG Sensor for Oocyte Characterization
A study testing Mechanical characterization in people with Infertility, run by Centre Hospitalier Universitaire de Besancon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Mechanical characterization
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of the EGG Sensor to Characterize Human Oocytes in IVF With ICSI
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.
Read more
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.
- Conditions
- Infertility
- Being tested
- Mechanical characterization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical characterizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EGG sensor | Experimental | 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. Receives: Device: Mechanical characterization |
| Standard | No intervention | Usual ICSI procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months
Secondary outcomes (10)
Differences in the mechanical characterization of an oocyte depending on whether or not it results in an early or late miscarriage.
Measured: 36 months
Differences in the mechanical characterization of an oocyte depending on whether or not it results in a clinical pregnancy.
Measured: 36 months
Differences in the mechanical characterization of an oocyte depending on whether or not it results in a biochemical pregnancy.
Measured: 36 months
Morphological characterization of mature oocytes (included in the ICSI procedure) and of abnormal or immature oocytes (excluded from the ICSI procedure).
Measured: 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.
Measured: 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..
Measured: 36 months
Biochemical pregnancy rates
Measured: 36 months
Early and late miscarriages rates
Measured: 36 months
Clinical pregnancy rates
Measured: 36 months
Live births rates
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497998
- Sponsor's protocol ID
- 2023/776
- Acronym
- EGG_SENSOR
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the EGG Sensor to Characterize Human Oocytes in IVF With ICSI
- ClinicalTrials.gov ID
- NCT06497998
- Acronym / sponsor ID
- EGG_SENSOR / 2023/776
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGG sensor | Experimental | Device: Mechanical characterizationMechanical 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. |
| Standard | No intervention | –Usual ICSI procedures |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical characterizationThe 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. | Device | EGG sensor |
Primary outcome
Differences in the global elasticity of the oocyte depending on whether or not it results in a live birth.
Time frame: 36 months
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.
Differences in the global viscosity behaviour of the oocyte depending on whether or not it results in a live birth
Time frame: 36 months
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.
Differences in the local elasticity of the oocyte depending on whether or not it results in a live birth
Time frame: 36 months
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.
Differences in the local viscosity of the pellucid membrane depending on whether or not it results in a live birth
Time frame: 36 months
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical characterization in people with Infertility, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Roux, MD, PhD (33 3 81 21 81 27, christophe.roux@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the global elasticity of the oocyte depending on whether or not it results in a live birth. (time frame: 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.