Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sperm separation device.
- Who it may be relevant to
- Registry conditions: DNA Damage, DNA Strand Breaks, Sperm DNA Fragmentation. Basic parameters: 18 years — 34 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
Overview
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.
Interventions
- Device sperm separation device
comparison of DNA damage between the 2 interventions and subsequent embryo development and pregnancy rates
Primary outcome measures
- Percentage of sperm with DNA fragmentation [Time frame: From enrollment until day after sample collection, approximately 1 month]
Secondary outcome measures (1)
- Concentration of sperm per mL [Time frame: From enrollment until day after sample collection, approximately 1 month]
Eligibility criteria
Inclusion criteria
- Samples with ≥15 M/mL spermatozoa concentration
- Female partner between 18 and 34 years old.
- Minimum of 4 fertilized eggs in gradient/swim prep group and 4 fertilized eggs in the Lenshooke prep group for each patient
Exclusion criteria
- Samples with <15 M/mL spermatozoa concentration
- female partner >35 years old
- female patient with recurrent pregnancy loss
- female patient with diminished ovarian reserve
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Prisma Health-Upstate Fertility Center of the Caroliinas — Greenville
Publications
- Ho CLT, Vaughan-Constable DR, Ramsay J, Jayasena C, Tharakan T, Yap T, Whiteman I, Graham N, Minhas S, Homa ST. The relationship between genitourinary microorganisms and oxidative stress, sperm DNA fragmentation and semen parameters in infertile men. Andrologia. 2022 Mar;54(2):e14322. doi: 10.1111/and.14322. Epub 2021 Nov 24. PMID 34817086
- Amor H, Hammadeh ME, Mohd I, Jankowski PM. Impact of heavy alcohol consumption and cigarette smoking on sperm DNA integrity. Andrologia. 2022 Aug;54(7):e14434. doi: 10.1111/and.14434. Epub 2022 Apr 28. PMID 35484935
- Cho CL, Agarwal A, Majzoub A, Esteves SC. Clinical utility of sperm DNA fragmentation testing: concise practice recommendations. Transl Androl Urol. 2017 Sep;6(Suppl 4):S366-S373. doi: 10.21037/tau.2017.07.28. PMID 29082146
- Rex AS, Aagaard J, Fedder J. DNA fragmentation in spermatozoa: a historical review. Andrology. 2017 Jul;5(4):622-630. doi: 10.1111/andr.12381. PMID 28718529
Identifiers
NCT: NCT06990841 · 2295231-1