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

Primary Purpose

Unexplained Infertility

Status

Completed

Phase

Phase 3

Locations

Turkey

Study Type

Interventional

Intervention

fertile chip

About this trial

This is an interventional treatment trial for Unexplained Infertility focused on measuring ICSI, sperm selection, fertile chip, ıcsı outcomes

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

fertile chip

classical ICSI procedure

Arm Description

sperm selection by using fertile chip and conventional methods

unexplained infertile couples who will be undertaken intracytoplasmic sperm injection (ICSI) for fertilisation

Outcomes

Primary Outcome Measures

increase fertilisation rate

Secondary Outcome Measures

Clinical pregnancy rates

Full Information

NCT ID

NCT02488434

First Posted

June 26, 2015

Last Updated

August 11, 2016

Sponsor

Baskent University

1. Study Identification

Unique Protocol Identification Number

NCT02488434

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baskent University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unexplained Infertility

Keywords

ICSI, sperm selection, fertile chip, ıcsı outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fertile chip

Arm Type

Active Comparator

Arm Description

sperm selection by using fertile chip and conventional methods

Arm Title

classical ICSI procedure

Arm Type

No Intervention

Arm Description

unexplained infertile couples who will be undertaken intracytoplasmic sperm injection (ICSI) for fertilisation

Intervention Type

Device

Intervention Name(s)

fertile chip

Intervention Description

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

Primary Outcome Measure Information:

Title

increase fertilisation rate

Time Frame

2 days

Secondary Outcome Measure Information:

Title

Clinical pregnancy rates

Time Frame

10 months

Other Pre-specified Outcome Measures:

Title

The number of freezing embryos

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Esra Bulgan Kılıçdağ, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Adana

State/Province

Yüreğir

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

1361459

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

Results Reference

background

PubMed Identifier

7060767

Citation

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.

Results Reference

background

PubMed Identifier

11113773

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

Results Reference

background

PubMed Identifier

24753434

Citation

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.

Results Reference

background

PubMed Identifier

6336697

Citation

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

Results Reference

background

PubMed Identifier

18485348

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. No abstract available.

Results Reference

background

PubMed Identifier

30542782

Citation

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.

Results Reference

derived

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

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