NCT02488434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

June 26, 2015

Last Update Submit

August 11, 2016

Conditions

Unexplained Infertility

Keywords

ICSIsperm selectionfertile chipıcsı outcomes

Outcome Measures

Primary Outcomes (1)

  • increase fertilisation rate

    2 days

Secondary Outcomes (1)

  • Clinical pregnancy rates

    10 months

Other Outcomes (1)

  • The number of freezing embryos

    6 months

Study Arms (2)

fertile chip

ACTIVE COMPARATOR

sperm selection by using fertile chip and conventional methods

Device: fertile chip

classical ICSI procedure

NO INTERVENTION

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

Interventions

fertile chipDEVICE

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

fertile chip

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • poor ovarian reserve which is diagnosed by Bologna criterias
  • abnormal semen analyse by WHO sperm criterias
  • abnormal ovulation problems,tubal patency or uterine cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Adana, Yüreğir, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 1361459BACKGROUND

  • 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.

    PMID: 7060767BACKGROUND

  • 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.

    PMID: 11113773BACKGROUND

  • 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.

    PMID: 24753434BACKGROUND

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

    PMID: 6336697BACKGROUND

  • 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.

    PMID: 18485348BACKGROUND

  • 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.

    PMID: 30542782DERIVED

Related Links

Study Officials

  • Esra Bulgan Kılıçdağ, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Doctor

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 2, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 12, 2016

Record last verified: 2016-08

Locations

TU(1)