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Clinical trial Recruiting at 1 site Interventional Ages 20 to 37

Comparing live birth rates after ICSI with artificial oocyte activation versus ICSI alone for 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

Run by ShangHai Ji Ai Genetics & IVF Institute · NCT06561451 · Data updated 2026-11-12

This trial tests whether adding artificial oocyte activation (AOA) to intracytoplasmic sperm injection (ICSI) helps couples with severe teratospermia have higher live birth rates.

Quick facts

Study typeInterventional
Ages20 Years to 37 Years
SexAll
Enrollment208 (estimated)
SponsorShangHai Ji Ai Genetics & IVF Institute
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedAugust 30, 2024
Main results expectedDecember 30, 2026
Study endsDecember 30, 2027
Registry record updatedFebruary 2, 2026
Trial IDNCT06561451 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 20–37 undergoing ovarian stimulation for ICSI whose male partners have severe teratospermia (99–100% abnormal sperm morphology) and who yield at least three mature oocytes are ideal candidates.

Probably not a fit

Patients with infertility primarily from female factors, those undergoing preimplantation genetic testing, with untreated hydrosalpinx or significant uterine abnormalities, abnormal parental karyotypes, recurrent pregnancy loss, or other contraindications to ART are unlikely to benefit or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled trial that assigns participants to ICSI plus AOA or to ICSI alone. In the ICSI+AOA arm, injected oocytes are exposed to the calcium ionophore A23187 for 10 minutes after sperm injection; in the ICSI arm, oocytes receive ICSI only. All oocytes are injected within four hours of follicular aspiration and cultured under standard conditions. The primary outcome is live birth rate.

Why it matters

Potential benefit: If successful, adding AOA to ICSI could increase live birth chances for couples affected by severe teratospermia.

How similar studies have gone: AOA has shown improved fertilization outcomes in case series and small studies—particularly for globozoospermia and prior fertilization failure—but randomized evidence showing higher live birth rates is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • ShangHai JIAI Genetics &I VF Institute
    Shanghai, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Male Infertility 24Teratospermia 2ShangHai Ji Ai Genetics & IVF Institute 2
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.