Back to resultsCleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available (Cleave-blast)
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Embryo transfer
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Infertile couple with only one embryo available for transfer
Exclusion Criteria:
- ineligible for study
Sites / Locations
- Banon Assiut
- Qena Fertility Center
- IbnSina IVF Center, IbnSina Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Day 3 transfer
Day 5 transfer
Arm Description
Transfer on day 3 when only one embryo is available
Transfer on day 5 when only one embryo is available
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate
Secondary Outcome Measures
Biochemical pregnancy rate
clinical pregnancy
Embryo development after In vitro fertilization cycle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04210414
Brief Title
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available
Acronym
Cleave-blast
Official Title
Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID19 Pandemic affected recruitment across 2020 and the stringent inclusion criteria makes the proposed sample size to be likely unachievable in reasonable period.
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
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
When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.
Detailed Description
Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.
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
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day 3 transfer
Arm Type
Experimental
Arm Description
Transfer on day 3 when only one embryo is available
Arm Title
Day 5 transfer
Arm Type
Experimental
Arm Description
Transfer on day 5 when only one embryo is available
Intervention Type
Other
Intervention Name(s)
Embryo transfer
Intervention Description
Transfer of only one embryo
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
within 20 weeks of gestation
Secondary Outcome Measure Information:
Title
Biochemical pregnancy rate
Time Frame
One month
Title
clinical pregnancy
Time Frame
7 weeks of gestation
Title
Embryo development after In vitro fertilization cycle
Time Frame
6 days after in vitro fertilization
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infertile couple with only one embryo available for transfer
Exclusion Criteria:
ineligible for study
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, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available
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