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

I

Istituto Clinico Humanitas

Status

Completed

Conditions

Infertility

Treatments

Procedure: Embryo transfer

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

388 patients

Sex

Female

Ages

18 to 38 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

388 participants in 2 patient groups

Blastocyst
Experimental group
Description:
Embryo transfer of at maximum 2 embryos at blastocyst stage
Treatment:
Procedure: Embryo transfer
Cleavage
Active Comparator group
Description:
Embryo transfer of at maximum 2 embryos at cleavage stage
Treatment:
Procedure: Embryo transfer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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