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Clinical Trials in India / NCT07626359
Starting soon Not applicable

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 · tracked via the Priya Life Science India tracker
Sponsor
Indira IVF Hospital Pvt Ltd
Phase
Not applicable
Started
2026-10-05
Last updated
2026-09-23

Condition(s) studied

Male

Investigational drug(s) / intervention(s)

Processed using density gradient centrifugationSecond Ejaculate (collected after 1-3 hours)

Processed using density gradient centrifugation: Processed using density gradient centrifugation

Second Ejaculate (collected after 1-3 hours): The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
45 Years
Healthy volunteers
No
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 outcome measure(s)

  • Ongoing Pregnancy Rate — 12 weeks of gestation
    Ongoing pregnancy rate

Trial sites (9)

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

More Indira IVF Hospital Pvt Ltd trials in India

Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART Starting soon
Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive Starting soon
Male Factor Infertility Across India Using Aphrodite Criteria Starting soon
FET in Adenomyosis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07626359 on ClinicalTrials.gov ↗ ← All trials in India