NCT06561451 Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
| NCT ID | NCT06561451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ShangHai Ji Ai Genetics & IVF Institute |
| Condition | Male Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2024-08-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 208 participants in total. It began in 2024-08-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Xiaoxi Sun, PhD
STUDY DIRECTOR
Shanghai JiAi Genetics & IVF Institute
Frequently Asked Questions
Who can join the NCT06561451 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 37 Years, studying Male Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06561451 currently recruiting?
Yes, NCT06561451 is actively recruiting participants. Contact the research team at lihe198900@163.com for enrollment information.
Where is the NCT06561451 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06561451 clinical trial?
NCT06561451 is sponsored by ShangHai Ji Ai Genetics & IVF Institute. The principal investigator is Xiaoxi Sun, PhD at Shanghai JiAi Genetics & IVF Institute. The trial plans to enroll 208 participants.