Clinical trial NCT02488434: The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility
Official title: The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unexplained Infertility
Keywords: ICSI
sperm selection
fertile chip
ıcsı outcomes
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: increase fertilisation rate
timeFrame: 2 days
Secondary outcomes:
measure: Clinical pregnancy rates
timeFrame: 10 months
Other outcomes:
measure: The number of freezing embryos
timeFrame: 6 months
Locations:
city: Adana
country: Turkey
facility: Baskent University Faculty of Medicine Department of Obstetrics and Gynecology Division of Reproductive and Endocrinology Unit
state: Yüreğir
Study officials:
affiliation: Division of Reproductive and Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Baskent University, Adana, Turkey
name: Esra Bulgan Kılıçdağ, MD
role: STUDY_DIRECTOR
References:
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