AzTrials
AzTrials

Male InfertilityNCT06561451

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

A study testing intracytoplasmic sperm injection and artificial oocyte activation and intracytoplasmic sperm injection in people with Male Infertility and Teratospermia, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 37 years
Conditions the study is for
Male Infertility, Teratospermia
What is being tested?
intracytoplasmic sperm injection and artificial oocyte activation and intracytoplasmic sperm injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteChina
Study dates
30 Aug 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 37 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

HE LI, MD contact

+8613817223099

lihe198900@163.com

China1 site, 1 recruiting

  • ShangHai JIAI Genetics &I VF Institute

    Shanghai

    LI HE, MD, +8613817223099

    Recruiting

Other trials in China

About this study

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

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.

Being tested
intracytoplasmic sperm injection and artificial oocyte activation, intracytoplasmic sperm injection
Medical subject headings
Infertility, Male, Teratozoospermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intracytoplasmic sperm injection and artificial oocyte activationProcedure or surgery

    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 injectionProcedure or surgery

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

Study groups in NCT06561451
Study groupRoleWhat they receive
ICSI+AOA groupExperimentalICSI+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.
Receives: Procedure: intracytoplasmic sperm injection and artificial oocyte activation
ICSI groupActive comparatora single sperm will be injected within 4 hours after the follicular aspiration.
Receives: Procedure: intracytoplasmic sperm injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth

    Delivery ≥22 weeks of gestation with heartbeat and breath.

    Measured: 1 year after embryo transfer

Secondary outcomes (10)

  1. Fertilization rate

    Fertilized oocytes with two pronuclei per MII oocyte injected

    Measured: 1 day after oocyte retrieval

  2. High-quality embryos on Day 3

    Seven or eight blastomeres of equal-size and <20% fragmentation by volume

    Measured: 3 days after oocyte retrieval

  3. hCG positivity

    Serum hCG level ≥10mIU/mL

    Measured: 14 days after embryo transfer

  4. Number and grading of embryos/blastocysts

    Number and grading of embryos/blastocysts suitable for freezing and transfer

    Measured: 6 days after oocyte retrieval

  5. Clinical pregnancy

    the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks.

    Measured: 6 weeks of gestation

  6. Ongoing pregnancy

    a viable pregnancy beyond 12 weeks of gestation

    Measured: 12 weeks of gestation

  7. Multiple pregnancy

    presence of more than one intrauterine sac at 6 weeks of gestation

    Measured: 6 weeks of gestation

  8. Cumulative live birth rate (within 6 months after randomization)

    Any live birth arising from embryo transfer within 6 months after randomization

    Measured: 1.5 years after the randomization

  9. Miscarriage rate

    A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy.

    Measured: 22 weeks of pregnancy

  10. Birth weights of the newborns

    Birth weights of the newborns

    Measured: 1 year after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start30 Aug 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561451
Sponsor's protocol ID
JIAI 2024-08
Status last verified
Jan 2026
First submitted
17 Aug 2024
Last updated
2 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 1351601

  • 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.

    PubMed 26346057

  • 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.

    PubMed 8408487

  • 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.

    PubMed 12524062

  • 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.

    PubMed 22205614

  • 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.

    PubMed 23706334

  • 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.

    PubMed 24656559

  • 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.

    PubMed 22493027

Questions about this trial

What is this clinical trial studying?

A study testing intracytoplasmic sperm injection and artificial oocyte activation and intracytoplasmic sperm injection in people with Male Infertility and Teratospermia, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact HE LI, MD (+8613817223099, lihe198900@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth (time frame: 1 year after embryo transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561451, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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