Adults 18 to 65, any sex, with Sperm DNA Fragmentation or Embryo Quality. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Day 3 High Quality Embryo PercentagePrimary· 3 days following fertilization
The primary outcome for intent to treat analysis. Day 3 high quality embryo percentage rate will be defined as the percentage of all viable 2PN embryos on day 3 with at least 6 cells and fragmentation/symmetry scores of 1-2. Scale: 1-6 for either fragmentation or symmetry. Lower scores are better. Calculated as ( the number of high-qualify-grade embryos yielded by a participant / the number of all viable 2PN embryos yielded by the participant x 100)
Group
Value
95% CI
Microfluidic Sperm Sorting
68
± 30.3
Conventional Sperm Preparation
66
± 25.8
Egg Fertilization RateSecondary· 1 day following fertilization
Number of eggs successfully fertilized (2PN embryo count) per number of mature eggs (MII egg count) retrieved per participant. 2PN grade indicates a successfully fertilized embryo. MII grade indicates a metaphase II stage egg which is mature enough to undergo fertilization. (The percentage is calculated for each participant as the number of 2PN embryos obtained / the number of MII eggs obtained x100). The resulting percentages were then averaged to determine the average fertilization rate for participants in each study arm.
Group
Value
95% CI
Microfluidic Sperm Sorting
75.2
± 17.8
Conventional Sperm Preparation
79.4
± 19.4
Pregnancy RateSecondary· 14 days following embryo transfer
Pregnancy rate will be defined as achieving a clinical pregnancy ( an ultrasound demonstrating gestational sac with yolk sac) per embryo transfer procedure attempt.
Group
Value
95% CI
Microfluidic Sperm Sorting
82
Conventional Sperm Preparation
78
Sponsor's own description
This is a randomized controlled trial of couples with a history of poor embryo quality undergoing a repeat in vitro fertilization (IVF) cycle for unexplained infertility. Couples will be randomized to sperm selection by the clinical standard of centrifugation and density-gradient processing compared to the microfluidic sperm sorting chip.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 31 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03085433.