Artificial Shrinkage of Fresh Blastocysts (BlastoCollapse)

April 22, 2024 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twin pregnancy rate by transfer
Time Frame: 5 weeks
Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.
5 weeks
Free DNA level
Time Frame: Baseline
Free DNA content contained in the drop of culture medium collected after transfer.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Anna AG GALA, MD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2018

Primary Completion (Actual)

August 20, 2021

Study Completion (Actual)

February 22, 2022

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimated)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL16_0267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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