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

Infertility Clinical Trial

— BlastoTrans  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639000
• Other study ID #: 736
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: October 3, 2016
• Start date: July 2010
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Embryo transfer
Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage

Locations

Country	Name	City	State
Italy	Paolo Emanuele Levi Setti	Rozzano (Milan)

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Glujovsky D, Blake D, Farquhar C, Bardach A. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002118. doi: 10.1002/14651858.CD002118.pub4. Review. Update in: Cochrane Database Syst Rev. 2016;(6):CD002118. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Number of patients achieving a clinical pregnancy divided for embryo transfers	8 weeks after inclusion	No
Secondary	Multiple pregnancy rate	Number of multiple pregnancies divided for pregnant patients	8 weeks after inclusion	Yes
Secondary	Implantation rate	Number of gestational sacs divided for number of transferred embryos	4 weeks after inclusion	No