Microfluidic versus density-gradient sperm preparation for ICSI with PGT-A using sibling oocytes
Official title: Evaluating the Utility of Implementing Microfluids for Sperm Preparation Compared to Conventional Method of Density Gradient Centrifugation in a PGT-A Program: a Sibling Oocyte Study
Run by ART Fertility Clinics LLC · NCT07093619 · Data updated 2026-11-12
This trial will test whether microfluidic sperm preparation leads to higher fertilization, blastulation, and euploid embryo rates than standard density-gradient centrifugation for people having ICSI with PGT-A.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | ART Fertility Clinics LLC Academic / other |
| Locations | 1 site (Abu Dhabi, Abu Dhabi Emirate) |
| Status | Recruiting |
| Started | September 12, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT07093619 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients undergoing ICSI with PGT‑A who produce at least eight MII oocytes per cycle and can provide fresh ejaculated sperm with ≥1 million/ml concentration, ≥10% motility, and a minimum 2 ml sample.
✕Probably not a fit
Patients using frozen oocytes, those with severe oligospermia (<1 million/ml), high round cell counts (>1 million/ml), or cases indicated for PGT‑M are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this sibling‑oocyte, single‑center interventional comparison, oocytes from the same stimulation cycle are split and fertilized by ICSI using sperm prepared either by a microfluidic laminar‑flow device or by conventional density‑gradient centrifugation. Fresh ejaculated sperm meeting minimum concentration and motility criteria are processed by the two methods, followed by embryo culture to blastocyst stage and PGT‑A biopsy on day 5–7. Outcomes include fertilization rate, blastulation rate, euploidy rate per sibling cohort, and embryo quality, with additional measures of processing time and laboratory handling. The trial is conducted at ART Fertility Clinics LLC in Abu Dhabi and excludes PGT‑M cases and severe oligospermia.
Why it matters
Potential benefit: If successful, microfluidic preparation could produce higher-quality and more frequently euploid embryos with less sperm DNA damage, potentially improving pregnancy chances and reducing lab time.
How similar studies have gone: Prior small studies and pilot data have reported improved embryo quality and pregnancy outcomes and suggest higher euploidy rates with microfluidic sperm selection, though larger randomized trials remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women with at least 8 MII per cycle after denudation (AFC≥8). 2. Women of all ages. 3. All embryo qualities ≥BL3CC at the time of biopsy on day 5, 6 and/or 7. 4. Fresh sperm used from ejaculate with a concentration ≥1 mill/ml and ≥10% motility (A+B). 5. Sperm samples with a minimum of 2 ml. Exclusion Criteria: * Frozen oocytes samples with severe oligospermia (≤1mill/ml). * PGT-M cases * Sperm with \> 1M/ml of round cells
Where it's running
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ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates Recruiting
Study contacts
- Study coordinator: Jonalyn Edades, Research Coordinator
- Email: jonalyn.edades@artfertilityclinics.com
- Phone: +97126528000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.