The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor

Study 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 (in vitro fertilization) laboratories 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 male 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 IVF / ICSI procedures result in a successful pregnancy of around 50%, 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 IVF Laboratories, 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.

Official Title
-----------------
The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor: a Randomized Controlled Trial

Conditions
-----------------
Male Infertility, Infertility, Male

Intervention / Treatment
-----------------
* Other: MicroFluidic Sperm Sorting Chips
* Other: Gradient-Density Centrifugation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apply to the IVF clinic due to male factor Volunteer Exclusion Criteria: Inadequate follicle development with medication Embryo does not have the appropriate quality for transfer Female-induced infertility Refuse to participate in research

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MicroFluidic Sperm Sorting Chips<br>Sperm Sorting microfluidic chips (for ICSI) will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm | Other: MicroFluidic Sperm Sorting Chips<br>* sperm selection of IVF treatment<br>|
| Active Comparator: gradient-density centrifugation<br>gradient-density centrifugation technique will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm | Other: Gradient-Density Centrifugation<br>* sperm selection of IVF treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare microfluid chip and density-gradient methods in terms of IVF success | measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level. | average of 1 year | 
| Compare microfluid chip and density-gradient methods in terms of embryo quality | 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. | average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microfluid chip, gradient-density, IVF, male factor