Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility Unexplained
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Compare microfluid chip and density-gradient methods in terms of embryo quality
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Compare microfluid chip and density-gradient methods in terms of embryo quality
Time Frame: average of 6 months
Embryo 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.
Compare microfluid chip and density-gradient methods in terms of IUI success
Time Frame: average of 6 months
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level