Clinical trial NCT06990841: Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
Official title: A Prospective Comparison of Two Different Sperm Preparation Techniques on the Prescence of DNA Fragmentation and Embryo Development
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: DNA Damage
DNA Strand Breaks
Sperm DNA Fragmentation
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Percentage of sperm with DNA fragmentation
timeFrame: From enrollment until day after sample collection, approximately 1 month
Secondary outcomes:
measure: Concentration of sperm per mL
timeFrame: From enrollment until day after sample collection, approximately 1 month
Other outcomes:
measure: Percentage of motile sperm
timeFrame: From enrollment until day after sample collection, approximately 1 month
measure: Percentage of Sperm with normal morphology Using Kruger Strict Criteria
timeFrame: From enrollment until day after sample collection, approximately 1 month
measure: Percentage of egg fertilization
timeFrame: From enrollment until a week after sample collection, approximately 5 weeks
measure: Numerical score of morphokinetic embryo development
timeFrame: From enrollment until a week after sample collection, approximately 5 weeks
measure: Qualitative embryo grade
timeFrame: From enrollment until a week after sample collection, approximately 5 weeks
measure: Percentage of patients that become pregnant and deliver a baby
timeFrame: From enrollment until a delivery of infant, up to 18 months
Locations:
city: Greenville
country: United States
facility: Prisma Health-Upstate Fertility Center of the Caroliinas
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate Fertility Center of the Carolinas
name: Richard Kordus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.