NCT02639000

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Infertility

Interventions

Type	Name	Description
PROCEDURE	Embryo transfer	Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage

Timeline

• Start date: 2010-07-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2015-12-23
• Last updated: 2016-10-04

Locations

1 site across 1 country: Italy