Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

484

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Indien
    • Karnataka
      • Bangalore, Karnataka, Indien, 560041
        • Indira IVF Hospital
        • Kontakt:
        • Underforsker:
          • Shyam Gupta, M.S. (OBGY)
        • Ledende efterforsker:
          • Jishnu PS, MSc
    • Maharashtra
      • Pune, Maharashtra, Indien, 411014
        • Indira IVF Hospital
        • Kontakt:
        • Underforsker:
          • Amol Lunkad, M.S. (OBGY)
        • Ledende efterforsker:
          • Rajesh Bhisade, MSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Live Birth rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Threshold Values for dsSDF and Global SDF
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indira IVF Hospital Pvt Ltd

Samarbejdspartnere

Bonraybio Co. Ltd.
ADVY Chemical Private Limited

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IIHL/EMB/PRS_001_2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

We will share IPD on request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner