Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497998
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-27
Brief Title:
EGG Sensor for Oocyte Characterization
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Use of the EGG Sensor to Characterize Human Oocytes in IVF With ICSI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGG_SENSOR
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None