Microfluidic versus density-gradient sperm preparation for ICSI with PGT-A using sibling oocytes
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
NA · ART Fertility Clinics LLC · NCT07093619
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | ART Fertility Clinics LLC (other) |
| Locations | 1 site (Abu Dhabi, Abu Dhabi Emirate) |
| Trial ID | NCT07093619 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Abu Dhabi, Abu Dhabi Emirate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Semen Analysis, ICSI, PGT-A, IVF, Sperm Preparation, euploid, fertilization rate, blastulation rate