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

• ClinicalTrials.gov Identifier: NCT02488434
• Recruitment Status: Completed
• First Posted: July 2, 2015
• Last Update Posted: August 12, 2016
• Sponsor: Baskent University
• Information provided by (Responsible Party): Selçuk Yetkinel, Baskent University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Unexplained Infertility	Device: fertile chip	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples
• Study Start Date: June 2015
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: fertile chip; sperm selection by using fertile chip and conventional methods	Device: fertile chip; a new method for sperm selection on ivf cycles by using microchannel system.
No Intervention: classical ICSI procedure; unexplained infertile couples who will be undertaken intracytoplasmic sperm injection (ICSI) for fertilisation

Outcome Measures

Primary Outcome Measures :

1. increase fertilisation rate [ Time Frame: 2 days ]

Secondary Outcome Measures :

1. Clinical pregnancy rates [ Time Frame: 10 months ]

Other Outcome Measures:

1. The number of freezing embryos [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

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

Adana, Yüreğir, Turkey

Sponsors and Collaborators

Baskent University

Investigators

• Study Director: Esra Bulgan Kılıçdağ, MD; Division of Reproductive and Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Baskent University, Adana, Turkey

More Information

Publications:

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. doi: 10.1016/0020-7292(92)90257-j.

Templeton AA, Penney GC. The incidence, characteristics, and prognosis of patients whose infertility is unexplained. Fertil Steril. 1982 Feb;37(2):175-82. doi: 10.1016/s0015-0282(16)46035-8.

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. doi: 10.1016/s0090-4295(00)00770-6.

Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tuzel 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.

Moghissi KS, Wallach EE. Unexplained infertility. Fertil Steril. 1983 Jan;39(1):5-21. doi: 10.1016/s0015-0282(16)46750-6.

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. No abstract available.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yetkinel S, Kilicdag EB, Aytac PC, Haydardedeoglu B, Simsek E, Cok T. Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial. J Assist Reprod Genet. 2019 Mar;36(3):403-409. doi: 10.1007/s10815-018-1375-2. Epub 2018 Dec 12.

• Responsible Party: Selçuk Yetkinel, Clinical Doctor, Baskent University
• ClinicalTrials.gov Identifier: NCT02488434
• Other Study ID Numbers: KA15/132
• First Posted: July 2, 2015
• Last Update Posted: August 12, 2016
• Last Verified: August 2016

Keywords provided by Selçuk Yetkinel, Baskent University:

ICSI; sperm selection; fertile chip; ıcsı outcomes

Additional relevant MeSH terms:

Infertility