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. (SE)

May 30, 2026 updated by: Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Bihar
      • Patna, Bihar, India, 800014
        • Recruitment
    • Karnataka
      • Bangalore, Karnataka, India, 560078
    • Maharashtra
      • Bhāndup, Maharashtra, India
        • Recruitment
      • Pune, Maharashtra, India
        • Recruitment
    • National Capital Territory of Delhi
      • Delhi, National Capital Territory of Delhi, India
        • Recruitment
    • Rajasthan
    • Uttar Pradesh
      • Allahābād, Uttar Pradesh, India
        • Recruitment
      • Lucknow, Uttar Pradesh, India
        • Recruitment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First Ejaculate
Processed using a centrifugation-free sperm sorting device
Procedure: Processed using density gradient centrifugation
Processed using density gradient centrifugation
Experimental: Second Ejaculate
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
Procedure: Second Ejaculate (collected after 1-3 hours)
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy Rate
Time Frame: 12 weeks of gestation
Ongoing pregnancy rate
12 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Time Frame: At the day of ICSI
Sperm motility and morphology after sperm sorting or second ejaculate collection.
At the day of ICSI
Blastocyst rate
Time Frame: Day 5&6 after ICSI
Blastocyst rate
Day 5&6 after ICSI
Good Blastocyst rate
Time Frame: Day 5&6 after ICSI
Total number of good blast
Day 5&6 after ICSI
Biochemical Pregnancy Rate
Time Frame: 2 weeks after embryo transfer
Biochemical Pregnancy Rate
2 weeks after embryo transfer
Implantation Rate
Time Frame: 4-6 weeks after embryo transfer
An embryo implantation rate is the percentage of transferred embryos that successfully attach to the uterine lining and develop into a clinical pregnancy
4-6 weeks after embryo transfer
Clinical Pregnancy Rate
Time Frame: 4-6 weeks after embryo transfer
measures the percentage of fertility treatment cycles (like IVF) that result in a pregnancy confirmed by an ultrasound showing a gestational sac or fetal heartbeat
4-6 weeks after embryo transfer
First trimester Miscarriage Rate
Time Frame: Till 12 weeks after embryo transfer
Miscarriages are very common, occurring in about 10% to 20% of all known pregnancies.
Till 12 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indira IVF Hospital Pvt Ltd

Investigators

  • Principal Investigator: Vipin Chandra, DGO, Indira IVF Hospital Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 5, 2026

Primary Completion (Estimated)

December 25, 2027

Study Completion (Estimated)

March 25, 2028

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIHL-UDR/P/007_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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