Humidified Culture and Live Birth After ICSI
- Conditions
- Infertility
- Interventions
- Other: Human embryo culture
- Registration Number
- NCT03823235
- Lead Sponsor
- Ibn Sina Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1837
- 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
- Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
- Thin endometrium
- Uterine anomaly and adhesion
- Adenomyosis
- Submucous myoma
- Endometriosis
- Severe medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Culture of human embryo in non-humidified incubator Human embryo culture Embryo culture after in vitro fertilization in incubator with no humidity
- Primary Outcome Measures
Name Time Method Live birth rate 30 weeks Viable neonate after 30 weeks of gestation per initiated cycle
- Secondary Outcome Measures
Name Time Method Cumulative ongoing pregnancy rate 12 weeks of gestation Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization
Preterm birth rate 37 weeks number of babies born before 37 weeks of gestation per total birth
Cleavage rate 6 days of culture Cleaved embryo per fertilized oocyte
Blastocyst formation rate 6 days of culture Formed blastocyst on day 5/6 from fertilized oocytes
Rate of high-quality blastocyst 6 days of culture Blastocysts ≥ 3.1.1 grade per fertilized oocyte
Ongoing pregnancy rate 12 weeks of gestation Continued pregnancy after 12 weeks of gestation per initiated cycle
Implantation rate 7 weeks of gestation Number of sacs with a heartbeat per number of embryo transferred
Ongoing implantation rate 12 weeks of gestation Number of sacs with a heartbeat per number of embryo transferred
Fertilization rate 6 days of culture fertilized oocytes with two pronuclei per Metaphase II injected
Rate of high-quality day-3 embryos 6 days of culture Embryos with seven or eight blastomeres of appropriate-size, and \< 10% fragmentation by volume per fertilized oocyte
Rate of utilizable blastocyst 6 days of culture Transferred and cryopreserved blastocysts from fertilized oocytes
Cumulative clinical pregnancy rate 7 weeks of gestation Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization
Very preterm birth 32 weeks number of babies born before 32 weeks of gestation per total birth
Low birth weight rate 40 weeks of gestation number of babies with \< 2500 gm per total birth
Cumulative live birth rate One year Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle
Clinical pregnancy rate 7 weeks of gestation Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle
Cumulative implantation rate 7 weeks of gestation Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Cumulative ongoing implantation rate 12 weeks of gestation Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Trial Locations
- Locations (3)
Qena Fertility Center
🇪🇬Qena, Egypt
IbnSina IVF Center
🇪🇬Sohag, Egypt
Banon Assiut
🇪🇬Assiut, Egypt