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

ShangHai Ji Ai Genetics & IVF Institute

Status: Enrolling

Conditions: Male Infertility; Teratospermia

Treatments: Procedure: intracytoplasmic sperm injection; Procedure: intracytoplasmic sperm injection and artificial oocyte activation

Study type: Interventional

Funder types: Other

Identifiers

NCT06561451

JIAI 2024-08

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 20 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups

ICSI+AOA group

Experimental group

Description:

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.

Treatment:

Procedure: intracytoplasmic sperm injection and artificial oocyte activation

ICSI group

Active Comparator group

Description:

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

Treatment:

Procedure: intracytoplasmic sperm injection