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

NCT ID: NCT02639000

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blastocyst

Embryo transfer of at maximum 2 embryos at blastocyst stage

Group Type: EXPERIMENTAL

Embryo transfer

Intervention Type: PROCEDURE

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

Cleavage

Embryo transfer of at maximum 2 embryos at cleavage stage

Group Type: ACTIVE_COMPARATOR

Embryo transfer

Intervention Type: PROCEDURE

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

Interventions

Embryo transfer

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• less than 4 fertilized eggs in day 1 after IVF

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Emanuele Levi-Setti, MD

Role: STUDY_DIRECTOR

Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center

Locations

Paolo Emanuele Levi Setti

Rozzano (Milan), , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 22786480 (View on PubMed)

Levi-Setti PE, Cirillo F, Smeraldi A, Morenghi E, Mulazzani GEG, Albani E. No advantage of fresh blastocyst versus cleavage stage embryo transfer in women under the age of 39: a randomized controlled study. J Assist Reprod Genet. 2018 Mar;35(3):457-465. doi: 10.1007/s10815-017-1092-2. Epub 2017 Nov 22.

Reference Type: DERIVED

PMID: 29168022 (View on PubMed)

Other Identifiers

736

Identifier Type: -

Identifier Source: org_study_id