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

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Conditions studied: Sperm DNA Fragmentation, Sperm DNA Impact on ART Outcomes

In brief

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.

Key facts

Study ID

NCT07621991

Run by

Indira IVF Hospital Pvt Ltd

People needed

484

Starts

2026-06-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-05

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Indira IVF Hospital — Bangalore, Karnataka, India
• Indira IVF Hospital — Pune, Maharashtra, India

Full record on ClinicalTrials.gov

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