Sperm Selection by Microfluidic Separation Improves Embryo Quality

NCT03085433 | Completed Results DMC FDA Device

• 1 other identifier: 16-21273
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Day 3 High Quality Embryo Percentage

  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)

  3 days following fertilization

Secondary Outcomes (2)

• Egg Fertilization Rate

  1 day following fertilization

• Pregnancy Rate

  14 days following embryo transfer

Study Arms (2)

Microfluidic sperm sorting

EXPERIMENTAL

Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.

Device: Microfluidic Sperm Sorting; Procedure: in vitro fertilization

Conventional sperm preparation

ACTIVE COMPARATOR

Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.

Procedure: in vitro fertilization

Interventions

Microfluidic Sperm Sorting DEVICE

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.

Also known as: FERTILE device

Microfluidic sperm sorting

in vitro fertilization PROCEDURE

ivf/icsi

Conventional sperm preparation; Microfluidic sperm sorting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Male partner with severe oligoasthenospermia (concentration \< 5 x 10\^6 spermatozoa/mL; motility\< 10%)
• Female partner with anovulation (PCOS, FHA)
• Female partner age \>41
• Female partner AFC\< 7
• Female partner with obstructed fallopian tubes (assessed in all patients prior to IVF)
• Use of oocyte donor
• Either Partner:
• Cancer diagnosis in either partner
• Any significant disease or psychiatric disorder that would interfere with consenting process
• Treatment History:
• o History of \>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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Quinn MM, Ribeiro S, Juarez-Hernandez F, Simbulan RK, Jalalian L, Cedars MI, Rosen MP. Microfluidic preparation of spermatozoa for ICSI produces similar embryo quality to density-gradient centrifugation: a pragmatic, randomized controlled trial. Hum Reprod. 2022 Jun 30;37(7):1406-1413. doi: 10.1093/humrep/deac099.

  PMID: 35522187 DERIVED

MeSH Terms

Conditions

Infertility; Infertility, Male

Interventions

Fertilization in Vitro

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Limitations and Caveats

The population studied was inclusive and did not attempt to isolate male factor infertility cases or patients with a history of elevated sperm DNA fragmentation.

Results Point of Contact

• Title: Clinical Research Team
• Organization: UCSF CRH

CRH.Research@ucsf.edu

4153534305

Study Officials

• Mitchell Rosen, M.D

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2017
• First Posted: March 21, 2017
• Study Start: June 20, 2017
• Primary Completion: October 30, 2021
• Study Completion: April 30, 2022
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)