Microswimup Procedure Efficacy Clinical Trial
| Verified date | February 2020 |
| Source | Cervesi Hospital, Cattolica, Italy |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this study is to evaluate the microbiological safety and the efficacy of a new not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure and to avoid mismatches by ensuring the same results of the standard techniques in terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a better euploid status of the embryos.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | January 2022 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 35 Years |
| Eligibility | Inclusion Criteria: - at least 8 oocytes retrieved at pickup - oocyte insemination with ICSI technique - only elective single embryo transfer (eSET) at blastocyst stage - sperm concentration = 1 X 106 /ml - absence of antibiotic treatment in the previous four weeks for male patients Exclusion Criteria: - recurrent miscarriages - more than three in vitro fertilization treatment - azoospermia |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Cervesi Hospital IVF Unit | Cattolica | Rimini |
| Italy | Primiterra Mariangela | Cattolica | Rimini |
| Lead Sponsor | Collaborator |
|---|---|
| Cervesi Hospital, Cattolica, Italy |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | euploid status | molecular analysis of blastocyst's biopsy | 6 months | |
| Primary | microbiological test | A standard bacteriological culture [based on inoculation of blood and "chocolate" agar plates and Brain-Heart Infusion broth, followed by incubation at 37°C for up to 72 hours] was performed in order to investigate the presence and amount of colonizing bacteria delivered with the semen at ejaculation and after treatment | 3 months | |
| Secondary | semen treatment efficacy | number of obtain blastocysts (%) and number of pregnancy (%) | 6 months |