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

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ClinicalTrials.gov Identifier: NCT02639000
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Embryo transfer Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
Study Start Date : July 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Blastocyst
Embryo transfer of at maximum 2 embryos at blastocyst stage
 Procedure: Embryo transfer
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
Active Comparator: Cleavage
Embryo transfer of at maximum 2 embryos at cleavage stage
 Procedure: Embryo transfer
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 8 weeks after inclusion ]
    Number of patients achieving a clinical pregnancy divided for embryo transfers


Secondary Outcome Measures :
  1. Multiple pregnancy rate [ Time Frame: 8 weeks after inclusion ]
    Number of multiple pregnancies divided for pregnant patients

  2. Implantation rate [ Time Frame: 4 weeks after inclusion ]
    Number of gestational sacs divided for number of transferred embryos


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639000


Locations
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Italy
Paolo Emanuele Levi Setti
Rozzano (Milan), Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Study Director: Paolo Emanuele Levi-Setti, MD Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02639000    
Other Study ID Numbers: 736
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female