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

Unexplained Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488434
• Other study ID #: KA15/132
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2015
• Last updated: August 11, 2016
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device InstitutionTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

Device:
• fertile chip
a new method for sperm selection on ivf cycles by using microchannel system.

Locations

Country	Name	City	State
Turkey	Baskent University Faculty of Medicine Department of Obstetrics and Gynecology Division of Reproductive and Endocrinology Unit	Adana	Yüregir

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tüzel E, Demirci U. Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species. Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17. — View Citation

Collins JA, Crosignani PG. Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. Review. — View Citation

Moghissi KS, Wallach EE. Unexplained infertility. Fertil Steril. 1983 Jan;39(1):5-21. Review. — View Citation

Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss. Fertil Steril. 2008 Jun;89(6):1603. doi: 10.1016/j.fertnstert.2008.03.002. Epub 2008 May 16. — View Citation

Templeton AA, Penney GC. The incidence, characteristics, and prognosis of patients whose infertility is unexplained. Fertil Steril. 1982 Feb;37(2):175-82. — View Citation

Zini A, Finelli A, Phang D, Jarvi K. Influence of semen processing technique on human sperm DNA integrity. Urology. 2000 Dec 20;56(6):1081-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of freezing embryos		6 months	No
Primary	increase fertilisation rate		2 days	No
Secondary	Clinical pregnancy rates		10 months	No