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NCT Number: NCT02488434

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

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.

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Key information

Conditions

Unexplained Infertility

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Baskent University Faculty of Medicine Department of Obstetrics and Gynecology Division of Reproductive and Endocrinology Unit

Adana, Yüreğir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fertile chip

Device

a new method for sperm selection on ivf cycles by using microchannel system.

Primary outcomes

  1. increase fertilisation rate

    Time frame: 2 days

Secondary outcomes

  1. Clinical pregnancy rates

    Time frame: 10 months

Other outcomes

  1. The number of freezing embryos

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2015
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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