Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539585
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality SMART Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART
Brief Summary:
The assisted reproduction success rate is affected by several factors including the age of the women oocyte quality and maturation state as well as sperm quality Imaging of the meiotic spindle may be crucial for determining the oocyte maturation and the optimal time of oocyte fertilization by intracytoplasmic sperm injection ICSI A new accurate and non-invasive method for selecting quality maturated oocytes based on meiotic spindle imaging is for women over 35 years of age will be introduced The evaluation of efficiency using meiotic spindle visibility in polarized light and its relative position to the polar body as indicator of oocyte maturity will be monitored and the optimal time for ICSI will be defined
Detailed Description:
One of the main strategies of infertility treatment is in vitro fertilization IVF The IVF success rate is affected by several key factors including the age of the women oocyte quality and maturation state as well as sperm quality Several authors have suggested that the presence position and retardance of the optically birefringent meiotic spindle MS are related to oocyte developmental competence affecting the quality of fertilization and embryo development Oocytes with normal spindle morphology are significantly more likely to produce euploid embryos compared with oocytes with meiotic spindles that are not visible or abnormal Adjusting the timing of intracytoplasmic sperm injection ICSI based on MS morphology has also been proposed It was shown that adjusting the time of ICSI based on the position of the MS with respect to the polar body PB increases the probability of successful fertilization for women over 35 years of age For the oocytes of patients over 35 years of age the longer incubation time enabled a greater number of oocytes to become fully mature MII phase and prepared for ICSI In this situation the MS status was an important indicator of oocyte immaturity
Patient will be randomized into three groups using Research Electronic Data Capture REDCap group 1 standard ICSI without MS imaging group 2 MS imaging followed by standard ICSI group 3 MS imaging and ICSI fertilization according MS status Oocytes from group 3 patients with MS evaluation will be fertilized according to MS status either 5-6 hours after ovum pick-up OPU or 7-8 hours after OPU Oocytes without MS evaluation will all fertilized 5-6 hours after OPU MS evaluation will take place in pre-prepared glass-bottomed dishes with about 5μl medium with the HEPES buffer covered with paraffin oil put to heat one hour before use The oocyte will be rotated using a needle so that Polar Body PB and MS are both well visible and photographs will be taken using optical microscope The MS status and the angle α between MS and PB will be obtained 3-4 hours after oocyte pick-up OPU At the same time the polarized-light microscopy image will be acquired polarized light microscopy at 100 magnification Specially for oocytes from group 3 patients with PBMS in close proximity angle between PB and MS 5 or MS not visible will be predicted as immature oocytes For these oocytes ICSI will be performed 4-5 h after the polarization microscopy evaluation ie 7-8 h after OPU For oocytes with MS clearly visible and PBMS not in close proximity angle between PB and MS 5 ICSI will be performed typically 2-3 h after the polarization microscopy evaluation ie 5-6 h after OPU as for patients from 1 and 2 groups ICSI will be performed according to standard protocol using ICSIholding micropipettes Microtech IVF Czech Republic polyvinylpyrrolidone ICSI Vitrolife Sweden and Eppendorf Hamburg Germany micromanipulation system equipped with thermoplate Tokaohit Japan The oocytes will be cultivated individually and their order preserved so that the other outcomes data from timelapse clinical results can be associated with individual oocytes We will also monitor the time from the human chorionic gonadotropin hCG administration to the completion of the actual fertilization The oocytes will be denuded HYASE-10X Vitrolife Sweden after OPU and the maturation stage will be examined Germinal Vesicle GV stage oocyte will not be included Oocytes and embryos in time-lapse incubator from the Japanese manufacturer Astec will be cultivated in a timelapse dish Origio Denmark Sage 1-Step Origio Denmark under paraffin oil OVOIL VITROLIFE Sweden at 370 C 6 CO2 and 5O2 Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body 16-20 h post ICSI Embryos will be cultivated for 122-144 h
Pilot findings will be confirmed in a randomized control trial ie to the efficiency of using MS visibility and relative position to the polar body as indicators of oocyte maturation in order to optimize ICSI timing will be evaluated
Patient will be randomized into three groups using Research Electronic Data Capture REDCap group 1 standard ICSI without MS imaging group 2 MS imaging followed by standard ICSI group 3 MS imaging and ICSI fertilization according MS status Oocytes from group 3 patients with MS evaluation will be fertilized according to MS status either 5-6 hours after ovum pick-up OPU or 7-8 hours after OPU Oocytes without MS evaluation will all fertilized 5-6 hours after OPU MS evaluation will take place in pre-prepared glass-bottomed dishes with about 5μl medium with the HEPES buffer covered with paraffin oil put to heat one hour before use The oocyte will be rotated using a needle so that Polar Body PB and MS are both well visible and photographs will be taken using optical microscope The MS status and the angle α between MS and PB will be obtained 3-4 hours after oocyte pick-up OPU At the same time the polarized-light microscopy image will be acquired polarized light microscopy at 100 magnification Specially for oocytes from group 3 patients with PBMS in close proximity angle between PB and MS 5 or MS not visible will be predicted as immature oocytes For these oocytes ICSI will be performed 4-5 h after the polarization microscopy evaluation ie 7-8 h after OPU For oocytes with MS clearly visible and PBMS not in close proximity angle between PB and MS 5 ICSI will be performed typically 2-3 h after the polarization microscopy evaluation ie 5-6 h after OPU as for patients from 1 and 2 groups ICSI will be performed according to standard protocol using ICSIholding micropipettes Microtech IVF Czech Republic polyvinylpyrrolidone ICSI Vitrolife Sweden and Eppendorf Hamburg Germany micromanipulation system equipped with thermoplate Tokaohit Japan The oocytes will be cultivated individually and their order preserved so that the other outcomes data from timelapse clinical results can be associated with individual oocytes We will also monitor the time from the human chorionic gonadotropin hCG administration to the completion of the actual fertilization The oocytes will be denuded HYASE-10X Vitrolife Sweden after OPU and the maturation stage will be examined Germinal Vesicle GV stage oocyte will not be included Oocytes and embryos in time-lapse incubator from the Japanese manufacturer Astec will be cultivated in a timelapse dish Origio Denmark Sage 1-Step Origio Denmark under paraffin oil OVOIL VITROLIFE Sweden at 370 C 6 CO2 and 5O2 Fertilization after ICSI will be defined as the presence of two pronuclei and 2 polar body 16-20 h post ICSI Embryos will be cultivated for 122-144 h
Pilot findings will be confirmed in a randomized control trial ie to the efficiency of using MS visibility and relative position to the polar body as indicators of oocyte maturation in order to optimize ICSI timing will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None