Infertility Assisted Reproductive Technology Clinical Trial
— BlastoCollapseOfficial title:
Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology
| Verified date | April 2024 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | February 22, 2022 |
| Est. primary completion date | August 20, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 43 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Montpellier University Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
Artificial shrinkage before fresh blastocyst transfer and in vitro fertilization outcomes: a pilot randomized controlled study. Reproductive BioMedicine Online
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* Note: There are 27 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 ßHCG blood test. | 5 weeks | |
| Secondary | Twin pregnancy rate by transfer | Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound. | 5 weeks | |
| Secondary | Free DNA level | Free DNA content contained in the drop of culture medium collected after transfer. | Baseline |