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

NCT06561451 · tracked via the Priya Life Science China tracker

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Phase

Not applicable

Started

2024-08-30

Last updated

2026-02-02

Condition(s) studied

Male InfertilityTeratospermia

Investigational drug(s) / intervention(s)

intracytoplasmic sperm injection and artificial oocyte activationintracytoplasmic sperm injection

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.

intracytoplasmic sperm injection: A single sperm will be injected within 4 hours after the follicular aspiration.

Study 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

Sex

ALL

Min age

20 Years

Max age

37 Years

Healthy volunteers

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

Primary outcome measure(s)

Live birth — 1 year after embryo transfer
Delivery ≥22 weeks of gestation with heartbeat and breath.

Trial sites (1)

Facility	City	Region	Status
ShangHai JIAI Genetics &I VF Institute	Shanghai	China	Recruiting

More ShangHai Ji Ai Genetics & IVF Institute trials in China

A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed FET Following a Freeze-all Strategy Active, not recruiting

Optimized PGT-M Strategy for Patients With No Proband Enrolling by invitation

Effect of GH on the Blastocyst Euploid Rate in AMA Patients Recruiting

ERA in Young Primary Infertile RIF Patients Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06561451 on ClinicalTrials.gov ↗ ← All trials in China