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Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years (BlastoTrans)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Embryo transfer
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female patients undergoing IVF procedures
  • age less than 39 years

Exclusion Criteria:

  • less than 4 fertilized eggs in day 1 after IVF

Sites / Locations

  • Paolo Emanuele Levi Setti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blastocyst

Cleavage

Arm Description

Embryo transfer of at maximum 2 embryos at blastocyst stage

Embryo transfer of at maximum 2 embryos at cleavage stage

Outcomes

Primary Outcome Measures

Pregnancy rate
Number of patients achieving a clinical pregnancy divided for embryo transfers

Secondary Outcome Measures

Multiple pregnancy rate
Number of multiple pregnancies divided for pregnant patients
Implantation rate
Number of gestational sacs divided for number of transferred embryos

Full Information

First Posted
December 15, 2015
Last Updated
October 3, 2016
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02639000
Brief Title
Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years
Acronym
BlastoTrans
Official Title
Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6). The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos. The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization. The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate. An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blastocyst
Arm Type
Experimental
Arm Description
Embryo transfer of at maximum 2 embryos at blastocyst stage
Arm Title
Cleavage
Arm Type
Active Comparator
Arm Description
Embryo transfer of at maximum 2 embryos at cleavage stage
Intervention Type
Procedure
Intervention Name(s)
Embryo transfer
Intervention Description
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Number of patients achieving a clinical pregnancy divided for embryo transfers
Time Frame
8 weeks after inclusion
Secondary Outcome Measure Information:
Title
Multiple pregnancy rate
Description
Number of multiple pregnancies divided for pregnant patients
Time Frame
8 weeks after inclusion
Title
Implantation rate
Description
Number of gestational sacs divided for number of transferred embryos
Time Frame
4 weeks after inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: female patients undergoing IVF procedures age less than 39 years Exclusion Criteria: less than 4 fertilized eggs in day 1 after IVF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Emanuele Levi-Setti, MD
Organizational Affiliation
Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center
Official's Role
Study Director
Facility Information:
Facility Name
Paolo Emanuele Levi Setti
City
Rozzano (Milan)
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22786480
Citation
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.
Results Reference
background
PubMed Identifier
29168022
Citation
Levi-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.
Results Reference
derived

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Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years

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