Clinical trial NCT04144244: Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles
Official title: Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility Unexplained
Infertility, Male
Keywords: microfluid chip
gradient-density
intrauterine insemination
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 176
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compare microfluid chip and density-gradient methods in terms of IUI success
timeFrame: average of 6 months
measure: Compare microfluid chip and density-gradient methods in terms of embryo quality
timeFrame: average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
Study officials:
References:
citation: Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
citation: Yetkinel S, Kilicdag EB, Aytac PC, Haydardedeoglu B, Simsek E, Cok T. Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial. J Assist Reprod Genet. 2019 Mar;36(3):403-409. doi: 10.1007/s10815-018-1375-2. Epub 2018 Dec 12.