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Double-strand Breaks and Impact on ART

Tundra lists 1 Double-strand Breaks and Impact on ART clinical trial. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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NOT YET RECRUITING

NCT07621991

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

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.

Gender: All

Ages: 21 Years - 55 Years

Updated: 2026-06-02

2 states

Sperm DNA Fragmentation

Sperm DNA Impact on ART Outcomes

Double-strand Breaks