Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART

Summary

The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). The main questions it aims to answer are:

* Can clinically relevant threshold values of dsSDF and global SDF predict live birth rates following ICSI?
* Does elevated dsSDF reduce live birth rates following ICSI? Participants undergoing ICSI as part of their routine fertility treatment will provide semen samples for global SDF and dsSDF assessment using the R10 Plus and R11 Plus kits, respectively, analysed using the LensHooke® X12 platform before and after sperm preparation. SDF and dsSDF assessments will be performed both prior to and following sperm washing for each participant. Embryos will be assessed from fertilization through embryo development, and following embryo transfer, participants will be prospectively followed for clinical outcomes ranging from biochemical pregnancy to live birth.

Conditions

• Sperm DNA Fragmentation
• Sperm DNA Impact on ART Outcomes

Interventions

DEVICE

LensHooke X12 Device

The LensHooke® X12 device is an automated sperm DNA fragmentation assessment platform based on the sperm chromatin dispersion (SCD) principle. In this study, the device will be used to assess global sperm DNA fragmentation (SDF) and double-strand sperm DNA fragmentation (dsSDF) using the R10 Plus and R11 Plus kits, respectively. The platform incorporates automated image acquisition and analysis to minimize operator-dependent variability and standardize sperm DNA fragmentation assessment. Semen samples collected from participants undergoing intracytoplasmic sperm injection (ICSI) will be analysed before and after sperm preparation to evaluate the association between sperm DNA damage parameters and assisted reproductive technology (ART) outcomes.

Sponsors & Collaborators

• Bonraybio Co. Ltd.

  collaborator UNKNOWN

• ADVY Chemical Private Limited

  collaborator UNKNOWN

• Indira IVF Hospital Pvt Ltd

  lead OTHER

Principal Investigators

• Vipin Chandra, M.B.B.S., D.G.O. · Indira IVF Hospital Limited, India

• Sandro Esteves, Ph.D. · Androfert Clinic, Brazil

• Naval Shah, MSc · Indira IVF Hospital Limited, India

• Shashank Sanagoudar, M.S. (OBGY) · Indira IVF Hospital Limited, India

• Divreena Talwar, MSc · Indira IVF Hospital Limited, India

• Jayesh Shinde, MSc · Indira IVF Hospital Limited, India

• Vivek Dave, Ph.D. · Indira IVF Hospital Limited, India

• Santoshi Kadam · ADVY Chemical Private Limited

• Cherry Yang, MSc · Bonraybio Co. Ltd.

• Tse-en Wang, Ph.D. · Bonraybio Co. Ltd.

Eligibility

Min Age

21 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-12-01

Completion

2027-12-01

FDA Device

Yes

Countries

• India

Study Locations