Infertility Assisted Reproductive Technology
Conditions
Keywords
Single blastocyst embryo transfer, Artificial Shrinkage, Clinical pregnancy rate, Cell free
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.
Interventions
PROCEDUREArtificial shrinkage
Artificial shrinkage of blastocyst
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed