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

ConditionsSperm DNA Fragmentation Sperm DNA Impact on ART Outcomes

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age21-55

SponsorIndira IVF Hospital Pvt Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

LensHooke X12 Device
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.

Treatment groups

484 Participants

are divided into 1 treatment group

Group A: ICSI Couples Undergoing SDF and dsSDF Assessment1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

24 weeks post embryo transfer

Secondary outcomes

Clinical Threshold Values for dsSDF and Global SDF

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).

Time frame

From fertilization assessment following intracytoplasmic sperm injection (ICSI) until live birth, approximately 18 months after participant enrolment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indira IVF Hospital Pvt Ltd

Lead sponsor

Bonraybio Co. Ltd.

Collaborator

ADVY Chemical Private Limited