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
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Condition or disease | Intervention/treatment | Phase |
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Infertility | Procedure: Embryo transfer | Not Applicable |
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 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 |
Arm | Intervention/treatment |
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Experimental: Blastocyst
Embryo transfer of at maximum 2 embryos at blastocyst stage
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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
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Procedure: Embryo transfer
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage |
- Pregnancy rate [ Time Frame: 8 weeks after inclusion ]Number of patients achieving a clinical pregnancy divided for embryo transfers
- Multiple pregnancy rate [ Time Frame: 8 weeks after inclusion ]Number of multiple pregnancies divided for pregnant patients
- Implantation rate [ Time Frame: 4 weeks after inclusion ]Number of gestational sacs divided for number of transferred embryos

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Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- female patients undergoing IVF procedures
- age less than 39 years
Exclusion Criteria:
- less than 4 fertilized eggs in day 1 after IVF

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
Italy | |
Paolo Emanuele Levi Setti | |
Rozzano (Milan), Italy, 20089 |
Study Director: | Paolo Emanuele Levi-Setti, MD | Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Infertility |