- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210414
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available (Cleave-blast)
June 12, 2022 updated by: Muhammad Fawzy, Ibn Sina Hospital
Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer
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.
Study Overview
Detailed Description
Recruitment is very slow.
The TSC will discuss termination next meeting with the DMC.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Banon Assiut
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Qena, Egypt, 123456
- Qena Fertility Center
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Sohag, Egypt, 12345
- IbnSina IVF Center, IbnSina Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Infertile couple with only one embryo available for transfer
Exclusion Criteria:
- ineligible for study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Day 3 transfer
Transfer on day 3 when only one embryo is available
|
Transfer of only one embryo
|
Experimental: Day 5 transfer
Transfer on day 5 when only one embryo is available
|
Transfer of only one embryo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ongoing pregnancy rate
Time Frame: within 20 weeks of gestation
|
within 20 weeks of gestation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biochemical pregnancy rate
Time Frame: One month
|
One month
|
clinical pregnancy
Time Frame: 7 weeks of gestation
|
7 weeks of gestation
|
Embryo development after In vitro fertilization cycle
Time Frame: 6 days after in vitro fertilization
|
6 days after in vitro fertilization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2020
Primary Completion (Actual)
November 10, 2021
Study Completion (Actual)
November 10, 2021
Study Registration Dates
First Submitted
December 21, 2019
First Submitted That Met QC Criteria
December 21, 2019
First Posted (Actual)
December 24, 2019
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 12, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IbnSina-ET
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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