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ClinicalTrials.gov ID

NCT07626359

Lead Sponsor

Indira IVF Hospital Pvt LtdOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

830Estimated

Last Update Posted

Jun 4, 2026Actual

Start Date

Aug 5, 2026Estimated

Primary Completion Date

Dec 25, 2027Estimated

Completion Date

Mar 25, 2028Estimated

Official Title

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.

Brief 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.

• Male

• Processed using density gradient centrifugation
• Second Ejaculate (collected after 1-3 hours)

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• • 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

Exclusion Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Indira IVF Hospital Pvt LtdOTHER

drsanagoudar@gmail.com8050406053