Actively Recruiting
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Led by ShangHai Ji Ai Genetics & IVF Institute · Updated on 2026-02-02
208
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 to 37 years at the time of ovarian stimulation for ICSI
- At least three matured oocytes collected
- Severe teratozoospermia defined as abnormal sperm morphology of 99-100%, including globozoospermia and tapered-head
You will not qualify if you...
- Presence of untreated hydrosalpinx
- Undergoing preimplantation genetic testing
- History of recurrent pregnancy loss defined as two or more spontaneous pregnancy losses
- Known uterine abnormalities such as congenital malformations, untreated uterine septum, adenomyosis, submucous myoma, endometrial polyps, or intrauterine adhesions
- Abnormal parental karyotyping or medical conditions that contraindicate assisted reproductive technology or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ShangHai JIAI Genetics &I VF Institute
Shanghai, China
Actively Recruiting
Research Team
H
HE LI, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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