Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459778
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-03
Brief Title:
Piezo-ICSI to Improve the Developmental Potential of Fertilized Oocytes in Aged Infertility Women With Assisted Reproductive Technology
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
A Single-center Randomized Controlled Trial on Piezo-ICSI Improving Oocyte Fertilization and Embryo Development in Elderly Infertile Patients
Status:
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:
None
Brief Summary:
The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection ICSI The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development Participants requested ICSI are asked to randomly culture equal numbers of oocyte and embryo with or without Piezo-ICSI At the time of injection two or more mature oocytes were split into two groups i conventional ICSI and ii Piezo-ICSI 5050 split
Detailed Description:
After being informed about the study and potential risks all participants will write the informed contents This study is a randomized controlled study compare different ICSI methods on the fertilization and embryo development Sibling oocytes were randomly divided into test group Piezo-ICSI and control group conventional ICSI
Specific method of randomization all the oocytes of each subject were distributed into two dishes dish 1 and dish 2 If the oocyte number is odd put the extra oocyte into dish 1 Using statistical software the two dishes were randomly treated as test group and control group Thus a random allocation table was generated and a separate random envelope was made for each subject The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher Each selected subject must open the random envelope The subjects were subjected to routine ovulation promotion and then the acquired oocytes and cumulus cell complexes COCs were obtained and fertilized in vitro The test group oocytes were fertilized with Piezo-ICSI while the control oocytes were fertilized with conventional ICSI
Thus half of the oocytes from each elderly infertile patient were treated with Piezo-ICSI
Specific method of randomization all the oocytes of each subject were distributed into two dishes dish 1 and dish 2 If the oocyte number is odd put the extra oocyte into dish 1 Using statistical software the two dishes were randomly treated as test group and control group Thus a random allocation table was generated and a separate random envelope was made for each subject The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher Each selected subject must open the random envelope The subjects were subjected to routine ovulation promotion and then the acquired oocytes and cumulus cell complexes COCs were obtained and fertilized in vitro The test group oocytes were fertilized with Piezo-ICSI while the control oocytes were fertilized with conventional ICSI
Thus half of the oocytes from each elderly infertile patient were treated with Piezo-ICSI
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