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Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles

Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144244
Enrollment
176
Registered
2019-10-30
Start date
2019-11-15
Completion date
2020-07-15
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male, Infertility Unexplained

Keywords

microfluid chip, gradient-density, intrauterine insemination

Brief summary

Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF and IUI cycles leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.

Detailed description

The increase in infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IUI procedures result in a successful pregnancy of around 10-15%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IUI cycles, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.

Interventions

sperm selection of IUI treatment

sperm selection of IUI treatment

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count \>5 million) * Volunteer

Exclusion criteria

* Inadequate follicle development with medication * Embryo does not have the appropriate quality for transfer * Tubal pathology * Total motile sperm count \< 5 million * Refuse to participate in research

Design outcomes

Primary

MeasureTime frameDescription
Compare microfluid chip and density-gradient methods in terms of IUI successaverage of 6 monthsmeasure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level
Compare microfluid chip and density-gradient methods in terms of embryo qualityaverage of 6 monthsEmbryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.

Countries

Turkey (Türkiye)

Contacts

Primary ContactPinar Ozcan, MD, Assoc Prof
drpinarozcan@hotmail.com+902124531700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026