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Not yet recruiting 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.

No phase Interventional Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Processed using density gradient centrifugation, Second Ejaculate (collected after 1-3 hours).
Who it may be relevant to
Registry conditions: Male. Basic parameters: 21 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Ongoing Pregnancy Rate [Time frame: 12 weeks of gestation]
Secondary outcome measures (7)
  • Sperm motility and morphology after sperm sorting or second ejaculate collection. [Time frame: At the day of ICSI]
  • Blastocyst rate [Time frame: Day 5&6 after ICSI]
  • Good Blastocyst rate [Time frame: Day 5&6 after ICSI]
  • Biochemical Pregnancy Rate [Time frame: 2 weeks after embryo transfer]
  • Implantation Rate [Time frame: 4-6 weeks after embryo transfer]
  • Clinical Pregnancy Rate [Time frame: 4-6 weeks after embryo transfer]
  • First trimester Miscarriage Rate [Time frame: Till 12 weeks after embryo transfer]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

India · 9 centers
  • Recruitment — Patna
  • Indira IVF Hospital Limited — Bangalore
  • Recruitment — Bhāndup
  • Recruitment — Pune
  • Recruitment — Delhi
  • Recruitment — Jaipur
  • LAB — Udaipur
  • Recruitment — Allahābād
  • … and 1 more center

Publications

  • Humaidan P, Haahr T, Povlsen BB, Kofod L, Laursen RJ, Alsbjerg B, Elbaek HO, Esteves SC. The combined effect of lifestyle intervention and antioxidant therapy on sperm DNA fragmentation and seminal oxidative stress in IVF patients: a pilot study. Int Braz J Urol. 2022 Jan-Feb;48(1):131-156. doi: 10.1590/S1677-5538.IBJU.2021.0604. PMID 34472769
  • https://www.sciencedirect.com/science/article/pii/S0015028215018749

Identifiers

NCT: NCT07626359 · IIHL-UDR/P/007_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗