Sperm DNA Fragmentation

Introduction The goal of this prospective observational study with an embedded randomized controlled trial (RCT) is to investigate the prevalence and clinical significance of sperm DNA fragmentation (damage to the genetic material in sperm cells) (SDF) among men undergoing fertility treatment and to determine whether an individualized lifestyle programme can reduce SDF and improve pregnancy outcomes. The study includes approximately 800 men undergoing fertility treatment at a Danish fertility clinic. Objectives and methods The main research questions are: 1. How common is elevated SDF among Danish men undergoing fertility treatment? 2. Is elevated SDF associated with reduced live birth rates and increased early pregnancy loss? 3. Can a 3-month individualized lifestyle intervention reduce SDF in men with high SDF levels (above 20%)? The whole cohort will participate in the observational study. Participants with SDF above 20% will be invited to take part in the randomized controlled trial. In the RCT researchers will compare men randomized to an individualized lifestyle intervention with men receiving standard fertility care to determine whether the intervention reduces sperm DNA fragmentation and improves subsequent pregnancy outcomes. All participants will: * Provide semen samples for sperm DNA fragmentation testing and routine semen analysis. * Provide blood samples to measure hormones and other health markers On the basis of SDF results participants will either: * Have SDF of 20% or lower: Continue with routine fertility treatment and follow up. * Have SDF above 20%: Be randomly assigned to either a personalised 3-month lifestyle programme or standard fertility care. Participants in the lifestyle programme will receive personalised advice on diet, physical activity, smoking, alcohol, sleep, stress management and antioxidant supplements. Ethics and dissemination The study has been approved by the Regional Committee on health research ethics and complies with the General Data Protection Regulation. Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed scientific journals, conference presentations, trial registry reporting, and communication with participants and relevant stakeholders.

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of oral Royal Jelly supplementation on sperm DNA fragmentation and pregnancy rates in couples with unexplained infertility. While routine semen analysis appears normal (normozoospermia) in these patients, underlying Sperm DNA Fragmentation (SDF) and oxidative stress are believed to contribute to reproductive failure. Participants will be randomized to receive either 750 mg of lyophilized Royal Jelly or a placebo daily for a period of 3 months (90 days). The study aims to evaluate whether the antioxidant properties of Royal Jelly can improve sperm chromatin integrity, reduce oxidative stress markers, and increase spontaneous pregnancy rates compared to the control group

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.

This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.

The goal of this clinical trial is to learn if the LensHooke CA0 device lowers DNA fragmentation in sperm samples compared to a gradient/swim-up technique. The main questions it aims to answer are: 1. Does the LensHooke® CA0 device reduce DNA fragmentation compared to the gradient/swim-up technique? 2. Does the LensHooke® CA0 device improve concentration, motility, and morphology compared to the gradient/swim-up technique? 3. Is sibling embryo fertilization and development the same? 4. Are pregnancy rates different between the 2 groups? 1 semen sample will be split between the 2 treatment techniques. Half of the partner's egg cohort will be injected via intra-cytoplasmic sperm using sperm processed by one technique and the other half of the cohort will be injected by the sperm processed by the other technique. Both methods will look at DNA fragmentation, concentration, motility, and morphology of the sperm. Both methods will be compared in the resulting embryos looking at fertilization, embryo development and pregnancy rates.