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

ShangHai Ji Ai Genetics & IVF Institute208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

208

Conditions

Male Infertility Teratospermia

Interventions

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 37 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Live birth

Delivery ≥22 weeks of gestation with heartbeat and breath.

Time frame: 1 year after embryo transfer

Secondary Outcomes

Fertilization rate

Fertilized oocytes with two pronuclei per MII oocyte injected

Time frame: 1 day after oocyte retrieval

High-quality embryos on Day 3

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

Time frame: 3 days after oocyte retrieval

hCG positivity

Serum hCG level ≥10mIU/mL

Time frame: 14 days after embryo transfer

Number and grading of embryos/blastocysts

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

Time frame: 6 days after oocyte retrieval

Clinical pregnancy

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

Time frame: 6 weeks of gestation

Ongoing pregnancy

a viable pregnancy beyond 12 weeks of gestation

Time frame: 12 weeks of gestation

Multiple pregnancy

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

Time frame: 6 weeks of gestation

Cumulative live birth rate (within 6 months after randomization)

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

Time frame: 1.5 years after the randomization

Miscarriage rate

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

Time frame: 22 weeks of pregnancy

Birth weights of the newborns