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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Embryo transfer

• Registration Number: NCT02639000
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-23
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 388

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blastocyst	Embryo transfer	Embryo transfer of at maximum 2 embryos at blastocyst stage
Cleavage	Embryo transfer	Embryo transfer of at maximum 2 embryos at cleavage stage

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	8 weeks after inclusion	Number of patients achieving a clinical pregnancy divided for embryo transfers

Secondary Outcome Measures

Name	Time	Method
Implantation rate	4 weeks after inclusion	Number of gestational sacs divided for number of transferred embryos
Multiple pregnancy rate	8 weeks after inclusion	Number of multiple pregnancies divided for pregnant patients

Trial Locations

Locations (1)

Paolo Emanuele Levi Setti; 🇮🇹 Rozzano (Milan), Italy