NCT07626359

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
830

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2026

Geographic Reach
1 country

9 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2028

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 30, 2026

Last Update Submit

May 30, 2026

Conditions

Male

Keywords

pregnancy rateSecond EjaculateAbstinenceMicrofluidicCA0

Outcome Measures

Primary Outcomes (1)

  • Ongoing Pregnancy Rate

    Ongoing pregnancy rate

    12 weeks of gestation

Secondary Outcomes (7)

  • Sperm motility and morphology after sperm sorting or second ejaculate collection.

    At the day of ICSI

  • Blastocyst rate

    Day 5&6 after ICSI

  • Good Blastocyst rate

    Day 5&6 after ICSI

  • Biochemical Pregnancy Rate

    2 weeks after embryo transfer

  • Implantation Rate

    4-6 weeks after embryo transfer

  • +2 more secondary outcomes

Study Arms (2)

First Ejaculate

EXPERIMENTAL

Processed using a centrifugation-free sperm sorting device

Procedure: Processed using density gradient centrifugation

Second Ejaculate

EXPERIMENTAL

The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.

Procedure: Second Ejaculate (collected after 1-3 hours)

Interventions

Processed using density gradient centrifugationPROCEDURE

Processed using density gradient centrifugation

First Ejaculate
Second Ejaculate (collected after 1-3 hours)PROCEDURE

The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.

Second Ejaculate

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Recruitment

Patna, Bihar, 800014, India

Location

Indira IVF Hospital Limited

Bangalore, Karnataka, 560078, India

Location

Recruitment

Bhāndup, Maharashtra, India

Location

Recruitment

Pune, Maharashtra, India

Location

Recruitment

Delhi, National Capital Territory of Delhi, India

Location

Recruitment

Jaipur, Rajasthan, India

Location

LAB

Udaipur, Rajasthan, 313001, India

Location

Recruitment

Allahābād, Uttar Pradesh, India

Location

Recruitment

Lucknow, Uttar Pradesh, India

Location

Related Publications (2)

  • 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: 34472769RESULT

  • https://www.sciencedirect.com/science/article/pii/S0015028215018749

    RESULT

Study Officials

  • Vipin Chandra, DGO

    Indira IVF Hospital Limited

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shashank Sanagoudar, MS

CONTACT

91-8050406053drsanagoudar@gmail.com

Sandro Esteves, PhD

CONTACT

s.esteves@androfert.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Clinical and Lab Operations

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 4, 2026

Study Start (Estimated)

August 5, 2026

Primary Completion (Estimated)

December 25, 2027

Study Completion (Estimated)

March 25, 2028

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data will be shared on request

Locations

IN(9)