Comparing live birth rates after ICSI with artificial oocyte activation versus ICSI alone for severe teratospermia
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 20 Years to 37 Years |
| Sex | All |
| Sponsor | ShangHai Ji Ai Genetics & IVF Institute Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06561451 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- ShangHai JIAI Genetics &I VF Institute — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: He Li, Md
- Email: lihe198900@163.com
- Phone: +8613817223099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.