Intracytoplasmic Sperm Injection Clinical Trial
— IS-MFluidicsOfficial title:
Clinical Outcomes Following the Sperm Selection by Rheotaxis and Thermotaxis in In-Situ Hand-made Microfluidics of Fluidic Walls in the Same ICSI Plate: a Randomized Controlled Trial
NCT number | NCT06243926 |
Other study ID # | e.23.I |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 8, 2024 |
Est. completion date | June 2024 |
Microfluidics technologies are proving their capability to select suitable sperm for ICSI, especially those that take advantage of the rheotaxic properties of sperm migration. In contrast to other sperm preparation methods such as Wash-Swim-Up and Density- Gradients-Centrifugation (DGC), microfluidics disregards washing and centrifugation steps along the procedure. However, microfluidics devices are costly and likely to fail to select motile sperm in dispermic samples. The investigators have recently described a novel approach for sperm selection by In-Situ handmade rheotaxis microfluidics of fluidic walls in the same ICSI plate. This methodology integrates a swim-over based on horizontal migration with a positive rheotaxis zone. The present study aims to deliver an unbiased comparison between two sperm selection techniques: DGC and In-Situ handmade rheotaxis microfluidics of fluidic walls (isM).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: - Patients undergoing ICSI - Female age under 40 years old - Number of mature oocytes (MII) upon oocyte retrieval = 6 - Male age under 50 years old - Total number of progressive sperm = 1 million Exclusion Criteria: - Patients with surgically retrieved sperm for ICSI - Cases using cryopreserved oocytes - Cases using cryopreserved sperm |
Country | Name | City | State |
---|---|---|---|
Spain | CREA Medicina de la Reproducción | Valencia |
Lead Sponsor | Collaborator |
---|---|
CREA Medicina de la Reproducción SL |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fertilization Rate (FR) | The proportion of two-pronuclei zygote divided by the total number of matured and microinjected oocytes (2pn/MII, %) | 16 to 20 hours post-ICSI (day 1) | |
Primary | Day 5 usable blastocyst rate (D5UBR) | The proportion of embryos classified as blastocysts at day 5 of development, which has been transferred and/or cryopreserved. | 108 to 113 hours post-ICSI (day 5) | |
Primary | Blastocyst quality grade | Blastocysts are categorized following the scale described by the Spanish Association of Reproduction Biology Studies (ASEBIR). The ASEBIR classification categorizes blastocysts based on their morphology into four groups: from A (highest, better outcome) to D (lowest, worse outcome). | 108 to 113 hours post-ICSI (day 5) | |
Secondary | Morphokinetics profile (MK PNa) | The proportion of embryos showing the appearance of pronuclei (PNa) out of the expected time frame. | from 16 to 20 hours post-ICSI (day 1) | |
Secondary | Morphokinetics profile (MK PNf) | The proportion of embryos showing the fading of pronuclei (PNf) out of the expected time frame. | from 24 to 25 hours post-ICSI (day 1) | |
Secondary | Morphokinetics profile (MK t2) | The proportion of embryos showing 2 cells (t2) out of the expected time frame. | from 24 to 28 hours post-ICSI (day 1) | |
Secondary | Morphokinetics profile (MK t4) | The proportion of embryos showing 4 cells (t4) out of the expected time frame. | from 37 to 41hours post-ICSI (day 2) | |
Secondary | Morphokinetics profile (MK t8) | The proportion of embryos showing 8 cells (t8) out of the expected time frame. | from 51 to 69 hours post-ICSI (day 3) | |
Secondary | Morphokinetics profile (MK tM) | The proportion of embryos with full cell compaction (morula; tM) out of the expected time frame. | from 81 to 96 hours post-ICSI (day 4) | |
Secondary | Morphokinetics profile (MK tSB) | The proportion of embryos starting to blastulate (tSB) out of the expected time frame. | from 99 to 101 hours post-ICSI (day 5) | |
Secondary | Morphokinetics profile (MK tB) | The proportion of embryos starting to blastulate (tB) out of the expected time frame. | from 108 to 113 hours post-ICSI (day 5) | |
Secondary | Implantation Rate (IR) | The proportion of embryos that were transferred that develop to a gestational sac | 5 to 6 gestational weeks | |
Secondary | Ongoing clinical pregnancy Rate (OCP) | The proportion of embryos that were transferred that develop at least to the stage of fetal heart activity | 6 to 8 gestational weeks |
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