The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility

Study Overview
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Brief Summary
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The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles.

Detailed Description
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The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles. On study arm sperm selection will be performed by using special microchannel system which is called fertile chip (FC) without using sperm wash procedure. This FC system leads to select lineer motile progressive sperm selection. In control group, sperm selection will be performed by classical way which sperm will be undertaken to sperm wash by gradient method. After selection of sperm in both arms, ICSI will be performed. The outcomes of ICSI schedule will be assesed by fertilization and clinical pregnancy rates.

Official Title
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The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples

Conditions
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Unexplained Infertility

Intervention / Treatment
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* Device: fertile chip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 20-37 year-old women normal tubal patency, normal uterine cavity, normal ovulation, between 20-40 year-old men normal semen analyse by WHO criterias unexplained infertile couples Exclusion Criteria: poor ovarian reserve which is diagnosed by Bologna criterias abnormal semen analyse by WHO sperm criterias abnormal ovulation problems,tubal patency or uterine cavity

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fertile chip<br>sperm selection by using fertile chip and conventional methods | Device: fertile chip<br>* a new method for sperm selection on ivf cycles by using microchannel system.<br>|
| No Intervention: classical ICSI procedure<br>unexplained infertile couples who will be undertaken intracytoplasmic sperm injection (ICSI) for fertilisation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase fertilisation rate |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rates |  | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ıcsı outcomes, ICSI, sperm selection, fertile chip