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

Not Applicable

Not yet recruiting

Interventions: Procedure: intracytoplasmic sperm injection
Procedure: intracytoplasmic sperm injection and artificial oocyte activation

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ICSI group	intracytoplasmic sperm injection	a single sperm will be injected within 4 hours after the follicular aspiration.
ICSI+AOA group	intracytoplasmic sperm injection and artificial oocyte activation	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.

Primary Outcome Measures

Name	Time	Method
Live birth	1 year after embryo transfer	Delivery ≥22 weeks of gestation with heartbeat and breath.

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	6 weeks of gestation	the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks.
High-quality embryos on Day 3	3 days after oocyte retrieval	Seven or eight blastomeres of equal-size and \<20% fragmentation by volume
Cumulative live birth rate (within 6 months after randomization)	1.5 years after the randomization	Any live birth arising from embryo transfer within 6 months after randomization
Multiple pregnancy	6 weeks of gestation	presence of more than one intrauterine sac at 6 weeks of gestation
Fertilization rate	1 day after oocyte retrieval	Fertilized oocytes with two pronuclei per MII oocyte injected
hCG positivity	14 days after embryo transfer	Serum hCG level ≥10mIU/mL
Number and grading of embryos/blastocysts	6 days after oocyte retrieval	Number and grading of embryos/blastocysts suitable for freezing and transfer
Ongoing pregnancy	12 weeks of gestation	a viable pregnancy beyond 12 weeks of gestation
Miscarriage rate	22 weeks of pregnancy	A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy.
Birth weights of the newborns	1 year after embryo transfer	Birth weights of the newborns