Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years
BlastoTrans
Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
1 other identifier
interventional
388
1 country
1
Brief Summary
Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 4, 2016
October 1, 2016
5.5 years
December 15, 2015
October 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy rate
Number of patients achieving a clinical pregnancy divided for embryo transfers
8 weeks after inclusion
Secondary Outcomes (2)
Multiple pregnancy rate
8 weeks after inclusion
Implantation rate
4 weeks after inclusion
Study Arms (2)
Blastocyst
EXPERIMENTALEmbryo transfer of at maximum 2 embryos at blastocyst stage
Cleavage
ACTIVE COMPARATOREmbryo transfer of at maximum 2 embryos at cleavage stage
Interventions
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
Eligibility Criteria
You may qualify if:
- female patients undergoing IVF procedures
- age less than 39 years
You may not qualify if:
- less than 4 fertilized eggs in day 1 after IVF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paolo Emanuele Levi Setti
Rozzano (Milan), 20089, Italy
Related Publications (2)
Glujovsky D, Blake D, Farquhar C, Bardach A. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002118. doi: 10.1002/14651858.CD002118.pub4.
PMID: 22786480BACKGROUNDLevi-Setti PE, Cirillo F, Smeraldi A, Morenghi E, Mulazzani GEG, Albani E. No advantage of fresh blastocyst versus cleavage stage embryo transfer in women under the age of 39: a randomized controlled study. J Assist Reprod Genet. 2018 Mar;35(3):457-465. doi: 10.1007/s10815-017-1092-2. Epub 2017 Nov 22.
PMID: 29168022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paolo Emanuele Levi-Setti, MD
Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 23, 2015
Study Start
July 1, 2010
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
October 4, 2016
Record last verified: 2016-10