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Artificial Shrinkage of Fresh Blastocysts (BlastoCollapse)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Infertility Assisted Reproductive Technology

Treatments

Procedure: Artificial shrinkage

Study type

Interventional

Funder types

Other

Identifiers

NCT02988544
RECHMPL16_0267

Details and patient eligibility

About

The aim of the study is to determine if collapsing an embryo (or making it fold compactly by taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in assisted reproductive technology (ART).

Women coming to our ART center will be randomized in two groups : the collapsing group and a control group.

Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be determined in each group and correlated to pregnancy occurrence.

Full description

This is a prospective randomized study designed to determine if artificial shrinkage (AS) before transfer of embryos impact clinical pregnancy rate in single blastocyst embryo transfer (SBET) cycle. Women elected for SBET will be randomized on transfer day in two arms:the AS group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer and a control group.

Clinical pregnancy rates will be compared. Secondarily, rate of monozygotic twin pregnancy and cell free DNA concentration in culture medium will be evaluated in the two groups.

Enrollment

150 patients

Sex

Female

Ages

18 to 43 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Couple eligible for a transfer of a single embryo at the blastocyst stage
  • Available couple for a follow up of 12 months

Exclusion criteria

  • Attempt with frozen embryo or frozen oocyte
  • Attempt with a pre-implantation diagnosis
  • Patient has not signed informed consent
  • Couple in a period of exclusion determined by a previous study
  • Couple under legal protection, guardianship or guardianship

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

Artificial shrinkage (AS) group
Experimental group
Description:
The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer
Treatment:
Procedure: Artificial shrinkage
Control group
No Intervention group
Description:
No intervention on blastocoelic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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