N/A
Completed N=386
Sperm Selection by Microfluidic Separation Improves Embryo Quality
Sperm DNA Fragmentation · Embryo Quality · Fertility Disorders · Infertility
Source: ClinicalTrials.gov NCT03085433 ↗
Enrolled (actual)
386
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Day 3 High Quality Embryo Percentage — 68; 66 percentage of high quality embryos
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Day 3 High Quality Embryo Percentage |
68; 66 | — |
| SECONDARY Egg Fertilization Rate |
75.2; 79.4 | — |
| SECONDARY Pregnancy Rate |
82; 78 | — |
Eligibility Criteria
Inclusion Criteria
- The target population includes couples planning in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI).
- Subjects with and without a history of prior IVF cycles will be included.
- All eligible couples where both partners are >=18 years of age will be asked to join the study.
Exclusion Criteria
- Male partner with severe oligoasthenospermia (concentration 41
- Female partner AFC 1 prior cycle cancellation due to poor response
- Treatment Plan:
- Embryo co-culture
- Use of adjunctive non-gonadotropin medications to improve embryo quality: growth hormone, sildenafil
Data sourced from ClinicalTrials.gov (NCT03085433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.