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

RecruitingNAAges 20 Years - 37 YearsAllShangHai Ji Ai Genetics & IVF Institute
NCT06561451 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age of women 20-37 years at the time of ovarian stimulation for ICSI 2. At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head. Exclusion Criteria: 1. Presence of hydrosalpinx which is not surgically treated 2. Undergoing preimplantation genetic testing 3. Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses) 4. Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions) 5. Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated
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What it tests

  • intracytoplasmic sperm injection and artificial oocyte activation
  • intracytoplasmic sperm injection
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Where

1 site
ShangHai JIAI Genetics &I VF Institute
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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