Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06561451 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 30, 2025 to Dec 30, 2026
    • Study completion date: Dec 30, 2026 to Dec 30, 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 30, 2025 to Dec 30, 2025
    • Study completion date: Aug 30, 2026 to Dec 30, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06561451
Lead Sponsor ShangHai Ji Ai Genetics & IVF Institute
Conditions
(from sponsor)		 Male Infertility, Teratospermia
Related terms Infertility, Male, Teratozoospermia
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov