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Artificial Shrinkage of Fresh Blastocysts (BlastoCollapse)

Primary Purpose

Infertility Assisted Reproductive Technology

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Artificial shrinkage
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility Assisted Reproductive Technology focused on measuring Single blastocyst embryo transfer, Artificial Shrinkage, Clinical pregnancy rate, Cell free

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Artificial shrinkage (AS) group

Control group

Arm Description

The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer

No intervention on blastocoelic

Outcomes

Primary Outcome Measures

Clinical pregnancy rate embryo transfer
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 Outcome Measures

Twin pregnancy rate by transfer
Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.
Free DNA level
Free DNA content contained in the drop of culture medium collected after transfer.

Full Information

First Posted
December 2, 2016
Last Updated
March 4, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02988544
Brief Title
Artificial Shrinkage of Fresh Blastocysts
Acronym
BlastoCollapse
Official Title
Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Assisted Reproductive Technology
Keywords
Single blastocyst embryo transfer, Artificial Shrinkage, Clinical pregnancy rate, Cell free

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial shrinkage (AS) group
Arm Type
Experimental
Arm Description
The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention on blastocoelic
Intervention Type
Procedure
Intervention Name(s)
Artificial shrinkage
Intervention Description
Artificial shrinkage of blastocyst
Primary Outcome Measure Information:
Title
Clinical pregnancy rate embryo transfer
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Twin pregnancy rate by transfer
Description
Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.
Time Frame
5 weeks
Title
Free DNA level
Description
Free DNA content contained in the drop of culture medium collected after transfer.
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna AG GALA, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Artificial Shrinkage of Fresh Blastocysts

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