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RECRUITING
NCT06561451
NA

Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia

Sponsor: ShangHai Ji Ai Genetics & IVF Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 37 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2024-08-30

Completion Date

2027-12-30

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

PROCEDURE

intracytoplasmic sperm injection and artificial oocyte activation

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.

PROCEDURE

intracytoplasmic sperm injection

A single sperm will be injected within 4 hours after the follicular aspiration.

Locations (1)

ShangHai JIAI Genetics &I VF Institute

Shanghai, China