Cleave-blast: Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available
Sponsor
Ibn Sina Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT04210414
Collaborator
(none)
83
3
2
22
27.7
1.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.
Study Design
Study Type:
Interventional
Actual Enrollment
:
83 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer
Actual Study Start Date
:
Jan 10, 2020
Actual Primary Completion Date
:
Nov 10, 2021
Actual Study Completion Date
:
Nov 10, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Day 3 transfer Transfer on day 3 when only one embryo is available |
Other: Embryo transfer
Transfer of only one embryo
|
| Experimental: Day 5 transfer Transfer on day 5 when only one embryo is available |
Other: Embryo transfer
Transfer of only one embryo
|
Outcome Measures
Primary Outcome Measures
- Ongoing pregnancy rate [within 20 weeks of gestation]
Secondary Outcome Measures
- Biochemical pregnancy rate [One month]
- clinical pregnancy [7 weeks of gestation]
- Embryo development after In vitro fertilization cycle [6 days after in vitro fertilization]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Infertile couple with only one embryo available for transfer
Exclusion Criteria:
- ineligible for study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banon Assiut | Assiut | Egypt | ||
| 2 | Qena Fertility Center | Qena | Egypt | 123456 | |
| 3 | IbnSina IVF Center, IbnSina Hospital | Sohag | Egypt | 12345 |
Sponsors and Collaborators
- Ibn Sina Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Muhammad Fawzy,
IVF Lab Director,
Ibn Sina Hospital
ClinicalTrials.gov Identifier:
NCT04210414
Other Study ID Numbers:
- IbnSina-ET
First Posted:
Dec 24, 2019
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: