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.

Starting soon · Not applicable

Conditions studied: Male

In brief

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.

Key facts

Study ID

NCT07626359

Run by

Indira IVF Hospital Pvt Ltd

People needed

830

Starts

2026-08-05

Expected to finish

2028-03-25

Last updated by the study team

2026-06-04

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Elevated SDF defined as DFI >20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.
• Male partners 21-45 years;
• Female partners 21-35 years.
• Undergoing IVF/ICSI.
• No known genetic or chromosomal abnormalities.
• Minimum 4 MII oocyte patients shall be included

You may not qualify if…

• Azoospermia or severe oligoasthenozoospermia (<1 million motile sperm/mL).
• Significant systemic disease (e.g., uncontrolled diabetes, malignancy).
• History of a prior ICSI cycle with no embryo development.
• Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (<7 mm) following endometrium preparation for embryo transfer

Where it is running

• Recruitment — Patna, Bihar, India
• Indira IVF Hospital Limited — Bangalore, Karnataka, India
• Recruitment — Bhāndup, Maharashtra, India
• Recruitment — Pune, Maharashtra, India
• Recruitment — Delhi, National Capital Territory of Delhi, India
• Recruitment — Jaipur, Rajasthan, India
• LAB — Udaipur, Rajasthan, India
• Recruitment — Allahābād, Uttar Pradesh, India
• Recruitment — Lucknow, Uttar Pradesh, India

Full record on ClinicalTrials.gov

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