---
title: Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
nct_id: NCT06561451
overall_status: RECRUITING
phase: NA
sponsor: ShangHai Ji Ai Genetics & IVF Institute
study_type: INTERVENTIONAL
primary_condition: Male Infertility
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06561451.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06561451"
ct_last_update_post_date: 2026-02-02
last_seen_at: "2026-05-12T06:24:14.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia

**Official Title:** 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

**NCT ID:** [NCT06561451](https://clinicaltrials.gov/study/NCT06561451)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 208
- **Lead Sponsor:** ShangHai Ji Ai Genetics & IVF Institute
- **Conditions:** Male Infertility, Teratospermia
- **Start Date:** 2024-08-30
- **Completion Date:** 2027-12-30
- **CT.gov Last Update:** 2026-02-02

## 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

- **Minimum age:** 20 Years
- **Maximum age:** 37 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **ICSI+AOA group** (EXPERIMENTAL) — 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 group** (ACTIVE_COMPARATOR) — a single sperm will be injected within 4 hours after the follicular aspiration.

## Interventions

- **intracytoplasmic sperm injection and artificial oocyte activation** (PROCEDURE) — 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** (PROCEDURE) — A single sperm will be injected within 4 hours after the follicular aspiration.

## Primary Outcomes

- **Live birth** _(time frame: 1 year after embryo transfer)_ — Delivery ≥22 weeks of gestation with heartbeat and breath.

## Secondary Outcomes

- **Fertilization rate** _(time frame: 1 day after oocyte retrieval)_
- **High-quality embryos on Day 3** _(time frame: 3 days after oocyte retrieval)_
- **hCG positivity** _(time frame: 14 days after embryo transfer)_
- **Number and grading of embryos/blastocysts** _(time frame: 6 days after oocyte retrieval)_
- **Clinical pregnancy** _(time frame: 6 weeks of gestation)_
- **Ongoing pregnancy** _(time frame: 12 weeks of gestation)_
- **Multiple pregnancy** _(time frame: 6 weeks of gestation)_
- **Cumulative live birth rate (within 6 months after randomization)** _(time frame: 1.5 years after the randomization)_
- **Miscarriage rate** _(time frame: 22 weeks of pregnancy)_
- **Birth weights of the newborns** _(time frame: 1 year after embryo transfer)_

## Locations (1)

- ShangHai JIAI Genetics &I VF Institute, Shanghai, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shanghai jiai genetics &i vf institute|shanghai||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06561451.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06561451*  
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