Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561451
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Control Trial to Compare the Live Birth Rate Between Intracytoplasmic Sperm Injection and Artificial Oocyte Activation and Intracytoplasmic Sperm Injection Alone in Patients With Severe Teratospermia
Status:
NOT_YET_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:
None
Brief Summary:
The goal of this clinical trial is to compare the live birth rate between intracytoplasmic sperm injection ICSI and artificial oocyte activation AOA vs intracytoplasmic sperm injection alone in patients with teratospermia The hypothesis is the live birth rate following ICSI and AOA is significantly higher than that by ICSI alone in patients with teratospermia This is a randomized controlled trial Participants will be randomly assigned into one of the two groups
ICSIAOA group a single sperm will be injected within 4 hours after the follicular aspiration All injected oocytes will be incubated in the calcium ionophore A23187 activation solution C9275-1MG Sigma USA for 10 min and cultured in the cleavage medium Cleavage Medium Cook United States under standard conditions
ICSI alone group a single sperm will be injected within 4 hours after the follicular aspiration
ICSIAOA group a single sperm will be injected within 4 hours after the follicular aspiration All injected oocytes will be incubated in the calcium ionophore A23187 activation solution C9275-1MG Sigma USA for 10 min and cultured in the cleavage medium Cleavage Medium Cook United States under standard conditions
ICSI alone group a single sperm will be injected within 4 hours after the follicular aspiration
Detailed Description:
None
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