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

Phase 3

Completed

• Conditions: Unexplained Infertility
• Interventions: Device: fertile chip

• Registration Number: NCT02488434
• Lead Sponsor: Baskent University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-11
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fertile chip	fertile chip	sperm selection by using fertile chip and conventional methods

Primary Outcome Measures

Name	Time	Method
increase fertilisation rate	2 days

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rates	10 months

Trial Locations

Locations (1)

Baskent University Faculty of Medicine Department of Obstetrics and Gynecology Division of Reproductive and Endocrinology Unit; 🇹🇷 Adana, Yüreğir, Turkey