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.

ConditionMale
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-45
SponsorIndira IVF Hospital Pvt Ltd

About this trial

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.

Eligibility criteria

Qualifiers

• 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.

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

830 Participants
are divided into 2 treatment groups

Sponsors and collaborators