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

October 3, 2016 updated by: Istituto Clinico Humanitas

Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rozzano (Milan), Italy, 20089
        • Paolo Emanuele Levi Setti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • less than 4 fertilized eggs in day 1 after IVF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 8 weeks after inclusion
Number of patients achieving a clinical pregnancy divided for embryo transfers
8 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple pregnancy rate
Time Frame: 8 weeks after inclusion
Number of multiple pregnancies divided for pregnant patients
8 weeks after inclusion
Implantation rate
Time Frame: 4 weeks after inclusion
Number of gestational sacs divided for number of transferred embryos
4 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Study Director: Paolo Emanuele Levi-Setti, MD, Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 23, 2015

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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