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

Sponsor
Baskent University (Other)
Overall Status
Completed
CT.gov ID
NCT02488434
Collaborator
(none)
122
1
2
14
8.7

Study Details

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
  • 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
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 :
Jun 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 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 [2 days]

Secondary Outcome Measures

  1. Clinical pregnancy rates [10 months]

Other Outcome Measures

  1. The number of freezing embryos [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Selçuk Yetkinel, Clinical Doctor, Baskent University
ClinicalTrials.gov Identifier:
NCT02488434
Other Study ID Numbers:
  • KA15/132
First Posted:
Jul 2, 2015
Last Update Posted:
Aug 12, 2016
Last Verified:
Aug 1, 2016
Keywords provided by Selçuk Yetkinel, Clinical Doctor, Baskent University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2016