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
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 design
Treatments tested in this trial
- LensHooke X12 Device
Treatment groups
Sponsors and collaborators
Indira IVF Hospital Pvt Ltd
Lead sponsor
Bonraybio Co. Ltd.
Collaborator
ADVY Chemical Private Limited
Collaborator