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OpenTrials
Completed

NCT Number: NCT02639000

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

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Paolo Emanuele Levi Setti

Rozzano (Milan), 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • less than 4 fertilized eggs in day 1 after IVF

Treatment and study plan

Embryo transfer

Procedure

Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage

Primary outcomes

  1. Pregnancy rate

    Time frame: 8 weeks after inclusion

    Number of patients achieving a clinical pregnancy divided for embryo transfers

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: BlastoTrans

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2015
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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