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Sperm Selection by Microfluidic Separation Improves Embryo Quality

NCT03085433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2025-12-31

Study results available
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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.

Conditions

  • Sperm DNA Fragmentation
  • Embryo Quality
  • Fertility Disorders
  • Infertility
  • Infertility, Male
  • Infertility Unexplained

Interventions

DEVICE

Microfluidic Sperm Sorting

Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.

PROCEDURE

in vitro fertilization

ivf/icsi

Sponsors & Collaborators

Principal Investigators

  • Mitchell Rosen, M.D · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2021-10-30
Completion
2022-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085433 on ClinicalTrials.gov