Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06561451

Live Birth Rate Between ICSI and AOA and ICSI 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Teratospermia Teratozoospermia Urogenital Diseases

Age range

20 year–37 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ShangHai JIAI Genetics &I VF Institute

Shanghai, China

Location status: Recruiting

Location contact

LI HE, MD

CONTACT

+8613817223099

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

  1. Live birth

    Time frame: 1 year after embryo transfer

    Delivery ≥22 weeks of gestation with heartbeat and breath.

Secondary outcomes

  1. Fertilization rate

    Time frame: 1 day after oocyte retrieval

    Fertilized oocytes with two pronuclei per MII oocyte injected

  2. 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. hCG positivity

    Time frame: 14 days after embryo transfer

    Serum hCG level ≥10mIU/mL

  4. Number and grading of embryos/blastocysts

    Time frame: 6 days after oocyte retrieval

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

  5. Clinical pregnancy

    Time frame: 6 weeks of gestation

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

  6. Ongoing pregnancy

    Time frame: 12 weeks of gestation

    a viable pregnancy beyond 12 weeks of gestation

  7. Multiple pregnancy

    Time frame: 6 weeks of gestation

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

  8. 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

  9. Miscarriage rate

    Time frame: 22 weeks of pregnancy

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

  10. Birth weights of the newborns

    Time frame: 1 year after embryo transfer

    Birth weights of the newborns

Study contacts

Contact information is provided by the study sponsor or research team.

HE LI, MD

CONTACT

[email protected]

+8613817223099

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 20, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.