Artificial Shrinkage of Fresh Blastocysts

Not Applicable

Completed

• Conditions: Infertility Assisted Reproductive Technology
• Interventions: Procedure: Artificial shrinkage

• Registration Number: NCT02988544
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-09
• Study Start: 2018-05-20
• Primary Completion: 2021-08-20
• Study Completion: 2022-02-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial shrinkage (AS) group	Artificial shrinkage	The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate embryo transfer	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 Outcome Measures

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

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France