Humidified Culture and Live Birth After ICSI

Study Overview
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Brief Summary
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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.

Official Title
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Humidified Incubator Effect on Live Birth Rate After ICSI

Conditions
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Infertility

Intervention / Treatment
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* Other: Human embryo culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culture of human embryo in non-humidified incubator<br>Embryo culture after in vitro fertilization in incubator with no humidity | Other: Human embryo culture<br>* humidifed or dry incubator<br>|
| No Intervention: Culture of human embryo in humidified incubator<br>Embryo culture after in vitro fertilization in incubator with humidity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Viable neonate after 30 weeks of gestation per initiated cycle | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative live birth rate | Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle | One year | 
| Ongoing pregnancy rate | Continued pregnancy after 12 weeks of gestation per initiated cycle | 12 weeks of gestation | 
| Cumulative ongoing pregnancy rate | Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization | 12 weeks of gestation | 
| Clinical pregnancy rate | Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle | 7 weeks of gestation | 
| Cumulative clinical pregnancy rate | Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization | 7 weeks of gestation | 
| Implantation rate | Number of sacs with a heartbeat per number of embryo transferred | 7 weeks of gestation | 
| Cumulative implantation rate | Number of sacs with a heartbeat per number of embryo transferred within one year of randomization | 7 weeks of gestation | 
| Ongoing implantation rate | Number of sacs with a heartbeat per number of embryo transferred | 12 weeks of gestation | 
| Cumulative ongoing implantation rate | Number of sacs with a heartbeat per number of embryo transferred within one year of randomization | 12 weeks of gestation | 
| Preterm birth rate | number of babies born before 37 weeks of gestation per total birth | 37 weeks | 
| Very preterm birth | number of babies born before 32 weeks of gestation per total birth | 32 weeks | 
| Low birth weight rate | number of babies with < 2500 gm per total birth | 40 weeks of gestation | 
| Fertilization rate | fertilized oocytes with two pronuclei per Metaphase II injected | 6 days of culture | 
| Cleavage rate | Cleaved embryo per fertilized oocyte | 6 days of culture | 
| Rate of high-quality day-3 embryos | Embryos with seven or eight blastomeres of appropriate-size, and < 10% fragmentation by volume per fertilized oocyte | 6 days of culture | 
| Blastocyst formation rate | Formed blastocyst on day 5/6 from fertilized oocytes | 6 days of culture | 
| Rate of high-quality blastocyst | Blastocysts ≥ 3.1.1 grade per fertilized oocyte | 6 days of culture | 
| Rate of utilizable blastocyst | Transferred and cryopreserved blastocysts from fertilized oocytes | 6 days of culture |