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Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.

NCT07626359 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2026-06-04

No results posted yet for this study

Summary

Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.

Conditions

  • Male

Interventions

PROCEDURE

Processed using density gradient centrifugation

Processed using density gradient centrifugation

PROCEDURE

Second Ejaculate (collected after 1-3 hours)

The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.

Sponsors & Collaborators

  • Indira IVF Hospital Pvt Ltd

    lead OTHER

Principal Investigators

  • Vipin Chandra, DGO · Indira IVF Hospital Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-05
Primary Completion
2027-12-25
Completion
2028-03-25

Countries

  • India

Study Locations

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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 NCT07626359 on ClinicalTrials.gov