Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods

Study Overview
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Brief Summary
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Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia. Materials and Methods: In this prospective study, the semen samples of the patients with astheno-teratozoospermia were divided into two groups for preparation with either the microfluidic or density gradient methods. Selected spermatozoa were used to fertilize the mature sibling oocytes. Semen parameters and embryo development on days 3 and 5 were assessed.

Official Title
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Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods

Conditions
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Reduced Sperm Motility, ICSI, Astheno Teratozoospermia, IVF

Intervention / Treatment
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* Device: Microfluidic sperm sorting chip
* Device: Density gradient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile men with astheno-teratozoospermia Women were aged from 18 to 39 Women had at least two mature oocytes. Exclusion Criteria: MI oocytes
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Density gradient method<br>Sperm prepared by density gradient method | Device: Density gradient<br>* Density gradient centrifugation<br>|
| Experimental: Microfluidic chip<br>Sperm prepared by microfluidic chip method | Device: Microfluidic sperm sorting chip<br>* Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen parameters after sperm preparation with either method: semen volume | semen volume (ml) | up to 7 months | 
| Semen parameters after sperm preparation with either method: sperm concentration | sperm concentration (106/ml) | up to 7 months | 
| Semen parameters after sperm preparation with either method: total motility | total motility (%) | up to 7 months | 
| Semen parameters after sperm preparation with either method: progressive motility | progressive motility (%) | up to 7 months | 
| Embryo development after sperm preparation with either method | Embryo development and blastocyst formation were evaluated on days 1, 3 and 5 based on the criteria reported by Veeck and Zaninovic, 2003 | up to 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sperm, ICSI, Abnormal morphology of sperm, Astheno Teratozoospermia, Microfluidic chip, IVF