Humidified Culture and Live Birth After ICSI
Humidified Incubator Effect on Live Birth Rate After ICSI
1 other identifier
interventional
1,837
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2020
CompletedJune 11, 2020
June 1, 2020
1.2 years
January 27, 2019
June 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Live birth rate
Viable neonate after 30 weeks of gestation per initiated cycle
30 weeks
Secondary Outcomes (18)
Cumulative live birth rate
One year
Ongoing pregnancy rate
12 weeks of gestation
Cumulative ongoing pregnancy rate
12 weeks of gestation
Clinical pregnancy rate
7 weeks of gestation
Cumulative clinical pregnancy rate
7 weeks of gestation
- +13 more secondary outcomes
Study Arms (2)
Culture of human embryo in non-humidified incubator
EXPERIMENTALEmbryo culture after in vitro fertilization in incubator with no humidity
Culture of human embryo in humidified incubator
NO INTERVENTIONEmbryo culture after in vitro fertilization in incubator with humidity
Interventions
humidifed or dry incubator
Eligibility Criteria
You may qualify if:
- 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
- to 40 years of age
- Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
- Tubal factors
You may not qualify if:
- Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
- Thin endometrium
- Uterine anomaly and adhesion
- Adenomyosis
- Submucous myoma
- Endometriosis
- Severe medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ibn Sina Hospitallead
- Banoon IVF Centercollaborator
- Quena IVF Centercollaborator
- Amshag IVF Centercollaborator
Study Sites (3)
Qena Fertility Center
Qina, Qena Governorate, 123456, Egypt
Banon Assiut
Asyut, Egypt
IbnSina IVF Center
Sohag, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lab Director
Study Record Dates
First Submitted
January 27, 2019
First Posted
January 30, 2019
Study Start
February 1, 2019
Primary Completion
March 27, 2020
Study Completion
March 27, 2020
Last Updated
June 11, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share