Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART
NCT: NCT07621991 · NOT_YET_RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART?
Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART is a clinical trial registered under NCT07621991. Current status: NOT_YET_RECRUITING.
What is the status of NCT07621991?
The current status of NCT07621991 (Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART) is: NOT_YET_RECRUITING.
When did Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART start?
Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART started on 2026-06-01.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.