Humidified Culture and Live Birth After ICSI

Infertility Clinical Trial

Official title:

Humidified Incubator Effect on Live Birth Rate After ICSI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823235
• Other study ID #: IbnSina-Humidity
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 27, 2020

Study information

• Verified date: June 2020
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1837
• Est. completion date: March 27, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Human embryo culture
humidifed or dry incubator

Locations

Country	Name	City	State
Egypt	Banon Assiut	Assiut
Egypt	Qena Fertility Center	Qena
Egypt	IbnSina IVF Center	Sohag

Sponsors (4)

Lead Sponsor	Collaborator
Ibn Sina Hospital	Amshag IVF Center, Banoon IVF Center, Quena IVF Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Viable neonate after 30 weeks of gestation per initiated cycle	30 weeks
Secondary	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
Secondary	Ongoing pregnancy rate	Continued pregnancy after 12 weeks of gestation per initiated cycle	12 weeks of gestation
Secondary	Cumulative ongoing pregnancy rate	Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization	12 weeks of gestation
Secondary	Clinical pregnancy rate	Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle	7 weeks of gestation
Secondary	Cumulative clinical pregnancy rate	Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization	7 weeks of gestation
Secondary	Implantation rate	Number of sacs with a heartbeat per number of embryo transferred	7 weeks of gestation
Secondary	Cumulative implantation rate	Number of sacs with a heartbeat per number of embryo transferred within one year of randomization	7 weeks of gestation
Secondary	Ongoing implantation rate	Number of sacs with a heartbeat per number of embryo transferred	12 weeks of gestation
Secondary	Cumulative ongoing implantation rate	Number of sacs with a heartbeat per number of embryo transferred within one year of randomization	12 weeks of gestation
Secondary	Preterm birth rate	number of babies born before 37 weeks of gestation per total birth	37 weeks
Secondary	Very preterm birth	number of babies born before 32 weeks of gestation per total birth	32 weeks
Secondary	Low birth weight rate	number of babies with < 2500 gm per total birth	40 weeks of gestation
Secondary	Fertilization rate	fertilized oocytes with two pronuclei per Metaphase II injected	6 days of culture
Secondary	Cleavage rate	Cleaved embryo per fertilized oocyte	6 days of culture
Secondary	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
Secondary	Blastocyst formation rate	Formed blastocyst on day 5/6 from fertilized oocytes	6 days of culture
Secondary	Rate of high-quality blastocyst	Blastocysts = 3.1.1 grade per fertilized oocyte	6 days of culture
Secondary	Rate of utilizable blastocyst	Transferred and cryopreserved blastocysts from fertilized oocytes	6 days of culture