Artificial Shrinkage of Fresh Blastocysts

NCT ID: NCT02988544

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-20
• Study Completion Date: 2022-02-22

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.

Conditions

Infertility Assisted Reproductive Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Artificial shrinkage (AS) group

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

Group Type: EXPERIMENTAL

Artificial shrinkage

Intervention Type: PROCEDURE

Artificial shrinkage of blastocyst

Control group

No intervention on blastocoelic

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Artificial shrinkage

Artificial shrinkage of blastocyst

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna AG GALA, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

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Other Identifiers

RECHMPL16_0267

Identifier Type: -

Identifier Source: org_study_id