Clinical trial NCT02988544: Artificial Shrinkage of Fresh Blastocysts
Official title: Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Assisted Reproductive Technology
Keywords: Single blastocyst embryo transfer
Artificial Shrinkage
Clinical pregnancy rate
Cell free
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Clinical pregnancy rate embryo transfer
timeFrame: 5 weeks
Secondary outcomes:
measure: Twin pregnancy rate by transfer
timeFrame: 5 weeks
measure: Free DNA level
timeFrame: Baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Anna AG GALA, MD
role: PRINCIPAL_INVESTIGATOR
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