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

January 29, 2026 updated by: ShangHai Ji Ai Genetics & IVF Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • ShangHai JIAI Genetics &I VF Institute
        • Contact:
          • LI HE, MD
          • Phone Number: +8613817223099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Active Comparator: ICSI group
a single sperm will be injected within 4 hours after the follicular aspiration.
Procedure: intracytoplasmic sperm injection
A single sperm will be injected within 4 hours after the follicular aspiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth
Time Frame: 1 year after embryo transfer
Delivery ≥22 weeks of gestation with heartbeat and breath.
1 year after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 1 day after oocyte retrieval
Fertilized oocytes with two pronuclei per MII oocyte injected
1 day after oocyte retrieval
High-quality embryos on Day 3
Time Frame: 3 days after oocyte retrieval
Seven or eight blastomeres of equal-size and <20% fragmentation by volume
3 days after oocyte retrieval
hCG positivity
Time Frame: 14 days after embryo transfer
Serum hCG level ≥10mIU/mL
14 days after embryo transfer
Number and grading of embryos/blastocysts
Time Frame: 6 days after oocyte retrieval
Number and grading of embryos/blastocysts suitable for freezing and transfer
6 days after oocyte retrieval
Clinical pregnancy
Time Frame: 6 weeks of gestation
the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks.
6 weeks of gestation
Ongoing pregnancy
Time Frame: 12 weeks of gestation
a viable pregnancy beyond 12 weeks of gestation
12 weeks of gestation
Multiple pregnancy
Time Frame: 6 weeks of gestation
presence of more than one intrauterine sac at 6 weeks of gestation
6 weeks of gestation
Cumulative live birth rate (within 6 months after randomization)
Time Frame: 1.5 years after the randomization
Any live birth arising from embryo transfer within 6 months after randomization
1.5 years after the randomization
Miscarriage rate
Time Frame: 22 weeks of pregnancy
A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy.
22 weeks of pregnancy
Birth weights of the newborns
Time Frame: 1 year after embryo transfer
Birth weights of the newborns
1 year after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Investigators

  • Study Director: Xiaoxi Sun, Phd, Shanghai JiAi Genetics & IVF Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 17, 2024

First Submitted That Met QC Criteria

August 17, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIAI 2024-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from the trial will be shared according to the International Committee of Medical Journal Editors guidelines. Individual participant data that underlie the results after deidentification (text, tables, figures and appendices) and the study protocol will be shared. On request, data can be shared with parties presenting relevant aims for the use of data. Data will be available from 3 months to 5 years following article publication.

IPD Sharing Time Frame

Data will be available from 3 months to 5 years following article publication

IPD Sharing Access Criteria

On request, data can be shared with parties presenting relevant aims for the use of data. Please contact the researcher through email: lihe198900@163.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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