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Completed

NCT Number: NCT02988544

Artificial Shrinkage of Fresh Blastocysts

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.

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Key information

Conditions

Infertility Assisted Reproductive Technology

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial shrinkage

Procedure

Artificial shrinkage of blastocyst

Primary outcomes

  1. Clinical pregnancy rate embryo transfer

    Time frame: 5 weeks

    Clinical pregnancy rate by transfer evaluate by the visualization of at least one gestational sac with fetal heart activity during pelvic ultrasound confirmed by a positive result of the quantitative βHCG blood test.

Secondary outcomes

  1. Twin pregnancy rate by transfer

    Time frame: 5 weeks

    Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.

  2. Free DNA level

    Time frame: Baseline

    Free DNA content contained in the drop of culture medium collected after transfer.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology

Acronym: BlastoCollapse

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 9, 2016
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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