Trials / Recruiting
RecruitingNCT06561451
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- Sponsor
- ShangHai Ji Ai Genetics & IVF Institute · Academic / Other
- Sex
- All
- Age
- 20 Years – 37 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | intracytoplasmic 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. |
| PROCEDURE | intracytoplasmic sperm injection | A single sperm will be injected within 4 hours after the follicular aspiration. |
Timeline
- Start date
- 2024-08-30
- Primary completion
- 2026-12-30
- Completion
- 2027-12-30
- First posted
- 2024-08-20
- Last updated
- 2026-02-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06561451. Inclusion in this directory is not an endorsement.