Humidified Culture and Live Birth After ICSI
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Human embryo culture
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Banon Assiut
- Qena Fertility Center
- IbnSina IVF Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Culture of human embryo in non-humidified incubator
Culture of human embryo in humidified incubator
Arm Description
Embryo culture after in vitro fertilization in incubator with no humidity
Embryo culture after in vitro fertilization in incubator with humidity
Outcomes
Primary Outcome Measures
Live birth rate
Viable neonate after 30 weeks of gestation per initiated cycle
Secondary Outcome Measures
Cumulative live birth rate
Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle
Ongoing pregnancy rate
Continued pregnancy after 12 weeks of gestation per initiated cycle
Cumulative ongoing pregnancy rate
Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization
Clinical pregnancy rate
Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle
Cumulative clinical pregnancy rate
Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization
Implantation rate
Number of sacs with a heartbeat per number of embryo transferred
Cumulative implantation rate
Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Ongoing implantation rate
Number of sacs with a heartbeat per number of embryo transferred
Cumulative ongoing implantation rate
Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Preterm birth rate
number of babies born before 37 weeks of gestation per total birth
Very preterm birth
number of babies born before 32 weeks of gestation per total birth
Low birth weight rate
number of babies with < 2500 gm per total birth
Fertilization rate
fertilized oocytes with two pronuclei per Metaphase II injected
Cleavage rate
Cleaved embryo per fertilized oocyte
Rate of high-quality day-3 embryos
Embryos with seven or eight blastomeres of appropriate-size, and < 10% fragmentation by volume per fertilized oocyte
Blastocyst formation rate
Formed blastocyst on day 5/6 from fertilized oocytes
Rate of high-quality blastocyst
Blastocysts ≥ 3.1.1 grade per fertilized oocyte
Rate of utilizable blastocyst
Transferred and cryopreserved blastocysts from fertilized oocytes
Full Information
NCT ID
NCT03823235
First Posted
January 27, 2019
Last Updated
June 9, 2020
Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Center, Amshag IVF Center
1. Study Identification
Unique Protocol Identification Number
NCT03823235
Brief Title
Humidified Culture and Live Birth After ICSI
Official Title
Humidified Incubator Effect on Live Birth Rate After ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Center, Amshag IVF Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1837 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Culture of human embryo in non-humidified incubator
Arm Type
Experimental
Arm Description
Embryo culture after in vitro fertilization in incubator with no humidity
Arm Title
Culture of human embryo in humidified incubator
Arm Type
No Intervention
Arm Description
Embryo culture after in vitro fertilization in incubator with humidity
Intervention Type
Other
Intervention Name(s)
Human embryo culture
Intervention Description
humidifed or dry incubator
Primary Outcome Measure Information:
Title
Live birth rate
Description
Viable neonate after 30 weeks of gestation per initiated cycle
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Cumulative live birth rate
Description
Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle
Time Frame
One year
Title
Ongoing pregnancy rate
Description
Continued pregnancy after 12 weeks of gestation per initiated cycle
Time Frame
12 weeks of gestation
Title
Cumulative ongoing pregnancy rate
Description
Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization
Time Frame
12 weeks of gestation
Title
Clinical pregnancy rate
Description
Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle
Time Frame
7 weeks of gestation
Title
Cumulative clinical pregnancy rate
Description
Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization
Time Frame
7 weeks of gestation
Title
Implantation rate
Description
Number of sacs with a heartbeat per number of embryo transferred
Time Frame
7 weeks of gestation
Title
Cumulative implantation rate
Description
Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Time Frame
7 weeks of gestation
Title
Ongoing implantation rate
Description
Number of sacs with a heartbeat per number of embryo transferred
Time Frame
12 weeks of gestation
Title
Cumulative ongoing implantation rate
Description
Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Time Frame
12 weeks of gestation
Title
Preterm birth rate
Description
number of babies born before 37 weeks of gestation per total birth
Time Frame
37 weeks
Title
Very preterm birth
Description
number of babies born before 32 weeks of gestation per total birth
Time Frame
32 weeks
Title
Low birth weight rate
Description
number of babies with < 2500 gm per total birth
Time Frame
40 weeks of gestation
Title
Fertilization rate
Description
fertilized oocytes with two pronuclei per Metaphase II injected
Time Frame
6 days of culture
Title
Cleavage rate
Description
Cleaved embryo per fertilized oocyte
Time Frame
6 days of culture
Title
Rate of high-quality day-3 embryos
Description
Embryos with seven or eight blastomeres of appropriate-size, and < 10% fragmentation by volume per fertilized oocyte
Time Frame
6 days of culture
Title
Blastocyst formation rate
Description
Formed blastocyst on day 5/6 from fertilized oocytes
Time Frame
6 days of culture
Title
Rate of high-quality blastocyst
Description
Blastocysts ≥ 3.1.1 grade per fertilized oocyte
Time Frame
6 days of culture
Title
Rate of utilizable blastocyst
Description
Transferred and cryopreserved blastocysts from fertilized oocytes
Time Frame
6 days of culture
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Humidified Culture and Live Birth After ICSI
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