Sponsor study identifier
observational
484
1 country
2
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2026
Actual (reported)June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2, 2026
Actual (reported)December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Live Birth rate
Live birth will be defined as the delivery of one or more live infants at or beyond 24 weeks of gestation following embryo transfer. Live birth rate will be calculated as the proportion of embryo transfer cycles resulting in at least one live birth.
24 weeks post embryo transfer
Clinical Threshold Values for dsSDF and Global SDF
From fertilization assessment following intracytoplasmic sperm injection (ICSI) until live birth, approximately 18 months after participant enrolment.
Infertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres will be prospectively enrolled based on predefined eligibility criteria. Semen samples collected on the day of ICSI will undergo assessment of global sperm DNA fragmentation (SDF) and double-strand sperm DNA fragmentation (dsSDF) using the LensHooke® X12 platform with the R10 Plus and R11 Plus kits, respectively. SDF assessments will be performed before and after sperm preparation.
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.
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The study population will consist of infertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres in India. Inclusion and exclusion criteria have been defined to establish a relatively homogeneous study population suitable for evaluating the impact of double-strand sperm DNA fragmentation (dsSDF) and global sperm DNA fragmentation (SDF) on assisted reproductive technology (ART) outcomes while minimizing potential confounding factors related to severe male factor infertility, female reproductive pathology, and adjunctive fertility interventions.
Indira IVF Hospital
Bangalore, Karnataka, 560041, India
Indira IVF Hospital
Pune, Maharashtra, 411014, India
Alvarez JG, Garcia-Peiro A, Barros A, Ferraz L, Sousa M, Sakkas D. Double strand DNA breaks in sperm: the bad guy in the crowd. J Assist Reprod Genet. 2023 Apr;40(4):745-751. doi: 10.1007/s10815-023-02748-5. Epub 2023 Feb 24.
Agarwal A, Barbarosie C, Ambar R, Finelli R. The Impact of Single- and Double-Strand DNA Breaks in Human Spermatozoa on Assisted Reproduction. Int J Mol Sci. 2020 May 29;21(11):3882. doi: 10.3390/ijms21113882.
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
First Submitted
May 27, 2026
First Posted
June 2, 2026
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2027
Impact of Sperm DNA Integrity on Artificial Reproductive Treatment (ART)
Contact the study team to confirm eligibility.
Wang TE, Lee CI, Huang CC, Tsao HM, Chang HC, Chang LS, Chang TA, Lee MS, Hsu CT. Innovative technology for evaluation of sperm DNA double-strand breaks diagnoses male factor infertility and prevents reproductive failures. Sci Rep. 2023 Nov 3;13(1):18996. doi: 10.1038/s41598-023-46049-4.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 5, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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