# 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** · NA · NOT_YET_RECRUITING · sponsor: **Indira IVF Hospital Pvt Ltd** · enrollment: 830 (estimated)

## Conditions studied

- Male

## Interventions

- **PROCEDURE:** Processed using density gradient centrifugation
- **PROCEDURE:** Second Ejaculate (collected after 1-3 hours)

## Key facts

- **NCT ID:** NCT07626359
- **Lead sponsor:** Indira IVF Hospital Pvt Ltd
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-10-05
- **Primary completion:** 2027-12-25
- **Final completion:** 2028-03-25
- **Target enrollment:** 830 (ESTIMATED)
- **Last updated:** 2026-09-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07626359

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07626359, "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.". Retrieved via MORVS 2026-10-21 from https://api.morvs.ai/clinical/NCT07626359. Licensed CC0.

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