Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-09 @ 2:18 AM
Study NCT ID:
NCT06561451
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2024-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Sponsor:
ShangHai Ji Ai Genetics & IVF Institute
Organization:
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:
RECRUITING
Status Verified Date:
2025-05
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 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:
ICSI+AOA 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.
ICSI+AOA 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:
False
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?:
False
Is an FDA AA801 Violation?: