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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 37
Healthy Volunteers: f
View:

• Age of women 20-37 years at the time of ovarian stimulation for ICSI

• At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.

Locations
Other Locations
China
ShangHai JIAI Genetics &I VF Institute
RECRUITING
Shanghai
Contact Information
Primary
HE LI, MD
lihe198900@163.com
+8613817223099
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 208
Treatments
Experimental: ICSI+AOA group
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.
Active_comparator: ICSI group
a single sperm will be injected within 4 hours after the follicular aspiration.
Related Therapeutic Areas
Sponsors
Leads: ShangHai Ji Ai Genetics & IVF Institute

This content was sourced from clinicaltrials.gov