RecruitingNot ApplicableNCT06561451

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

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

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Enrollment

208 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

Male infertility Teratospermia

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.

Eligibility

Min Age: 20 YearsMax Age: 37 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called intracytoplasmic sperm injection and a procedure called intracytoplasmic sperm injection and artificial oocyte activation for people with male infertility and teratospermia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREintracytoplasmic 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.

PROCEDUREintracytoplasmic sperm injection

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