Humidified Culture and Live Birth After ICSI

Ibn Sina Hospital1,837 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

1,837

Conditions

Infertility

Interventions

Human embryo cultureOTHER

humidifed or dry incubator

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

Qena Fertility Center

Qina, Qena Governorate, Egypt

Banon Assiut

Asyut, Egypt

IbnSina IVF Center

Sohag, Egypt

Outcomes

Primary Outcomes

Live birth rate

Viable neonate after 30 weeks of gestation per initiated cycle

Time frame: 30 weeks

Secondary Outcomes

Cumulative live birth rate

Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle

Time frame: One year

Ongoing pregnancy rate

Continued pregnancy after 12 weeks of gestation per initiated cycle

Time frame: 12 weeks of gestation

Cumulative ongoing pregnancy rate

Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization

Time frame: 12 weeks of gestation

Clinical pregnancy rate

Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle

Time frame: 7 weeks of gestation

Cumulative clinical pregnancy rate

Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization

Time frame: 7 weeks of gestation

Implantation rate

Number of sacs with a heartbeat per number of embryo transferred

Time frame: 7 weeks of gestation

Cumulative implantation rate

Number of sacs with a heartbeat per number of embryo transferred within one year of randomization

Data from ClinicalTrials.gov

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