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

3 giugno 2026 aggiornato da: Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd

A Prospective Trial Assessing the Impact of Double-strand Breaks on ART Outcomes and Predicting Its Clinical Thresholds

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This prospective, two-centre observational study is designed to evaluate 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). Although conventional sperm DNA fragmentation assays assess overall DNA damage, they do not differentiate between single- and double-strand DNA breaks. Emerging evidence suggests that dsSDF represents a more severe form of genomic damage with limited oocyte repair potential and may therefore have a greater impact on embryological and reproductive outcomes, particularly live birth.

A total of 484 infertile couples undergoing ICSI treatment at two tertiary IVF centres in India will be prospectively recruited based on predefined eligibility criteria. Semen samples will be collected on the day of ICSI following 2-3 days of sexual abstinence. Global SDF and dsSDF assessments will be performed using the LensHooke® X12 platform with the R10 Plus and R11 Plus kits, respectively. SDF testing will be conducted both before and after sperm preparation to evaluate the impact of sperm washing on DNA fragmentation parameters.

Embryos derived from enrolled participants will be prospectively assessed from fertilization through embryo development. Following embryo transfer, participants will be prospectively followed for clinical outcomes including biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, and live birth.

Receiver operating characteristic (ROC) curve analysis will be used to derive clinically relevant threshold values for dsSDF and global SDF. Multivariable regression analyses will additionally be performed to evaluate the predictive value of dsSDF and global SDF for ART outcomes while adjusting for potential confounding factors. The findings of this study are expected to improve the clinical interpretation of sperm DNA damage assessment and support the integration of dsSDF into individualized reproductive care.

Tipo di studio

Osservativo

Iscrizione (Stimato)

484

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560041
        • Indira IVF Hospital
        • Contatto:
        • Sub-investigatore:
          • Shyam Gupta, M.S. (OBGY)
        • Investigatore principale:
          • Jishnu PS, MSc
    • Maharashtra
      • Pune, Maharashtra, India, 411014
        • Indira IVF Hospital
        • Contatto:
        • Sub-investigatore:
          • Amol Lunkad, M.S. (OBGY)
        • Investigatore principale:
          • Rajesh Bhisade, MSc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • Males aged 21-55 years undergoing ICSI treatment for male factor infertility.
  • Women with age 21-35 for self-oocyte pickup cycles
  • Oocyte donor cycles with recipient age of 21-35 years of age
  • Sperm with a minimum total motile sperm count of 2.0 million/mL and a minimum volume of 1.2 mL
  • Patients not underwent sperm DNA fragmentation testing
  • 2-3 days of abstinence prior to intracytoplasmic sperm injection (ICSI).

Exclusion Criteria:

  • Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with <2 million/ml sperm count)
  • Known systemic diseases (e.g., diabetes mellitus).
  • Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration.
  • Untreated endometrial or uterine factors or adnexal pathology
  • Embryos underwent preimplantation genetic testing for aneuploidy testing.
  • Patients with thin endometrium (<7mm)
  • Patients opted or underwent donor sperms as the male gamete source.
  • Patients underwent antioxidant treatment in last 6 months prior to ICSI treatment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
ICSI Couples Undergoing SDF and dsSDF Assessment
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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Live Birth rate
Lasso di tempo: 24 weeks post embryo transfer
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical Threshold Values for dsSDF and Global SDF
Lasso di tempo: From fertilization assessment following intracytoplasmic sperm injection (ICSI) until live birth, approximately 18 months after participant enrolment.
Clinically relevant threshold values for double-strand sperm DNA fragmentation (dsSDF) and global sperm DNA fragmentation (SDF) will be derived using receiver operating characteristic (ROC) curve analysis based on their predictive ability for live birth and other assisted reproductive technology (ART) outcomes. Thresholds will be identified as the values associated with a significant reduction in reproductive outcomes following intracytoplasmic sperm injection (ICSI).
From fertilization assessment following intracytoplasmic sperm injection (ICSI) until live birth, approximately 18 months after participant enrolment.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Indira IVF Hospital Pvt Ltd

Collaboratori

Bonraybio Co. Ltd.
ADVY Chemical Private Limited

Investigatori

  • Investigatore principale: Vipin Chandra, M.B.B.S., D.G.O., Indira IVF Hospital Limited, India
  • Direttore dello studio: Sandro Esteves, Ph.D., Androfert Clinic, Brazil
  • Cattedra di studio: Naval Shah, MSc, Indira IVF Hospital Limited, India
  • Cattedra di studio: Shashank Sanagoudar, M.S. (OBGY), Indira IVF Hospital Limited, India
  • Cattedra di studio: Divreena Talwar, MSc, Indira IVF Hospital Limited, India
  • Cattedra di studio: Jayesh Shinde, MSc, Indira IVF Hospital Limited, India
  • Cattedra di studio: Vivek Dave, Ph.D., Indira IVF Hospital Limited, India
  • Cattedra di studio: Cherry Yang, MSc, Bonraybio Co. Ltd.
  • Cattedra di studio: Tse-en Wang, Ph.D., Bonraybio Co. Ltd.
  • Cattedra di studio: Santoshi Kadam, ADVY Chemical Private Limited

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IIHL/EMB/PRS_001_2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

We will share IPD on request

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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