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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 August 2016
Main ID:  NCT02488434
Date of registration: 26/06/2015
Prospective Registration: No
Primary sponsor: Baskent University
Public title: The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility
Scientific title: The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples
Date of first enrolment: June 2015
Target sample size: 122
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02488434
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Turkey
Contacts
Name:     Esra Bulgan Kiliçdag, MD
Address: 
Telephone:
Email:
Affiliation:  Division of Reproductive and Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Baskent University, Adana, Turkey
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Unexplained Infertility
Intervention(s)
Device: fertile chip
Primary Outcome(s)
increase fertilisation rate [Time Frame: 2 days]
Secondary Outcome(s)
Clinical pregnancy rates [Time Frame: 10 months]
Secondary ID(s)
KA15/132
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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