NCT06561451

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

August 17, 2024

Last Update Submit

January 29, 2026

Conditions

Male InfertilityTeratospermia

Outcome Measures

Primary Outcomes (1)

  • Live birth

    Delivery ≥22 weeks of gestation with heartbeat and breath.

    1 year after embryo transfer

Secondary Outcomes (10)

  • Fertilization rate

    1 day after oocyte retrieval

  • High-quality embryos on Day 3

    3 days after oocyte retrieval

  • hCG positivity

    14 days after embryo transfer

  • Number and grading of embryos/blastocysts

    6 days after oocyte retrieval

  • Clinical pregnancy

    6 weeks of gestation

  • +5 more secondary outcomes

Study Arms (2)

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.

Procedure: intracytoplasmic sperm injection and artificial oocyte activation

ICSI group

ACTIVE COMPARATOR

a single sperm will be injected within 4 hours after the follicular aspiration.

Procedure: intracytoplasmic sperm injection

Interventions

intracytoplasmic sperm injection and artificial oocyte activationPROCEDURE

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+AOA group
intracytoplasmic sperm injectionPROCEDURE

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

ICSI group

Eligibility Criteria

Age20 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of hydrosalpinx which is not surgically treated
  • Undergoing preimplantation genetic testing
  • Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses)
  • Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions)
  • Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShangHai JIAI Genetics &I VF Institute

Shanghai, China

RECRUITING

Related Publications (8)

  • Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.

    PMID: 1351601BACKGROUND

  • Yeste M, Jones C, Amdani SN, Patel S, Coward K. Oocyte activation deficiency: a role for an oocyte contribution? Hum Reprod Update. 2016 Jan-Feb;22(1):23-47. doi: 10.1093/humupd/dmv040. Epub 2015 Sep 7.

    PMID: 26346057BACKGROUND

  • Van Steirteghem AC, Nagy Z, Joris H, Liu J, Staessen C, Smitz J, Wisanto A, Devroey P. High fertilization and implantation rates after intracytoplasmic sperm injection. Hum Reprod. 1993 Jul;8(7):1061-6. doi: 10.1093/oxfordjournals.humrep.a138192.

    PMID: 8408487BACKGROUND

  • De Vos A, Van De Velde H, Joris H, Verheyen G, Devroey P, Van Steirteghem A. Influence of individual sperm morphology on fertilization, embryo morphology, and pregnancy outcome of intracytoplasmic sperm injection. Fertil Steril. 2003 Jan;79(1):42-8. doi: 10.1016/s0015-0282(02)04571-5.

    PMID: 12524062BACKGROUND

  • Lu YH, Gao HJ, Li BJ, Zheng YM, Ye YH, Qian YL, Xu CM, Huang HF, Jin F. Different sperm sources and parameters can influence intracytoplasmic sperm injection outcomes before embryo implantation. J Zhejiang Univ Sci B. 2012 Jan;13(1):1-10. doi: 10.1631/jzus.B1100216.

    PMID: 22205614BACKGROUND

  • Greco E, Scarselli F, Fabozzi G, Colasante A, Zavaglia D, Alviggi E, Litwicka K, Varricchio MT, Minasi MG, Tesarik J. Sperm vacuoles negatively affect outcomes in intracytoplasmic morphologically selected sperm injection in terms of pregnancy, implantation, and live-birth rates. Fertil Steril. 2013 Aug;100(2):379-85. doi: 10.1016/j.fertnstert.2013.04.033. Epub 2013 May 23.

    PMID: 23706334BACKGROUND

  • Vanden Meerschaut F, Nikiforaki D, Heindryckx B, De Sutter P. Assisted oocyte activation following ICSI fertilization failure. Reprod Biomed Online. 2014 May;28(5):560-71. doi: 10.1016/j.rbmo.2014.01.008. Epub 2014 Jan 31.

    PMID: 24656559BACKGROUND

  • Vanden Meerschaut F, Nikiforaki D, De Gheselle S, Dullaerts V, Van den Abbeel E, Gerris J, Heindryckx B, De Sutter P. Assisted oocyte activation is not beneficial for all patients with a suspected oocyte-related activation deficiency. Hum Reprod. 2012 Jul;27(7):1977-84. doi: 10.1093/humrep/des097. Epub 2012 Apr 4.

    PMID: 22493027BACKGROUND

MeSH Terms

Conditions

Infertility, MaleTeratozoospermia

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Xiaoxi Sun, PhD

    Shanghai JiAi Genetics & IVF Institute

    STUDY DIRECTOR

Central Study Contacts

HE LI, MD

CONTACT

+8613817223099lihe198900@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

August 30, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data will be available from 3 months to 5 years following article publication
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.

Locations

CN(1)