Humidified Culture and Live Birth After ICSI

Humidified Incubator Effect on Live Birth Rate After ICSI

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 Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Human embryo culture

• Study Type: Interventional
• Enrollment (Actual): 1837
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Banon Assiut
  • Qena, Egypt, 123456
    • Qena Fertility Center
  • Sohag, Egypt
    • IbnSina IVF Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Collaborators: Banoon IVF Center; Quena IVF Center; Amshag IVF Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IbnSina-Humidity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No