Humidified Culture and Live Birth After ICSI

Ibn Sina Hospital

Status: Completed

Conditions: Infertility

Treatments: Other: Human embryo culture

Study type: Interventional

Funder types: Other

Identifiers

NCT03823235

IbnSina-Humidity

Details and patient eligibility

About

Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.

Enrollment: 1,837 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women undergoing a first or second ICSI attempts
• Primary or secondary infertility with a BMI of < 31 kg/m2
• Duration of infertility of ≥ 18 months and normal baseline ultrasonography
• 18 to 40 years of age
• Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
• Tubal factors

Exclusion criteria

• Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
• Thin endometrium
• Uterine anomaly and adhesion
• Adenomyosis
• Submucous myoma
• Endometriosis
• Severe medical condition

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,837 participants in 2 patient groups

Culture of human embryo in non-humidified incubator

Experimental group

Description:

Embryo culture after in vitro fertilization in incubator with no humidity

Treatment:

Other: Human embryo culture

Culture of human embryo in humidified incubator

No Intervention group

Description:

Embryo culture after in vitro fertilization in incubator with humidity