search
Back to results

Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles

Primary Purpose

Infertility Unexplained, Infertility, Male

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MicroFluidic Sperm Sorting Chips
Gradient-Density Centrifugation
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility Unexplained focused on measuring microfluid chip, gradient-density, intrauterine insemination

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count >5 million)
  • Volunteer

Exclusion Criteria:

  • Inadequate follicle development with medication
  • Embryo does not have the appropriate quality for transfer
  • Tubal pathology
  • Total motile sperm count < 5 million
  • Refuse to participate in research

Sites / Locations

  • Bezmialem UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MicroFluidic Sperm Sorting Chips

gradient-density centrifugation

Arm Description

Sperm Sorting microfluidic chips will be used when preparing sperm of male partner and IUI will be made with separated sperm

gradient-density centrifugation technique will be used when preparing sperm of male partner and IUI will be made with separated sperm

Outcomes

Primary Outcome Measures

Compare microfluid chip and density-gradient methods in terms of IUI success
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level
Compare microfluid chip and density-gradient methods in terms of embryo quality
Embryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2019
Last Updated
February 11, 2020
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT04144244
Brief Title
Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles
Official Title
Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF and IUI cycles leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
Detailed Description
The increase in infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IUI procedures result in a successful pregnancy of around 10-15%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IUI cycles, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Unexplained, Infertility, Male
Keywords
microfluid chip, gradient-density, intrauterine insemination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MicroFluidic Sperm Sorting Chips
Arm Type
Experimental
Arm Description
Sperm Sorting microfluidic chips will be used when preparing sperm of male partner and IUI will be made with separated sperm
Arm Title
gradient-density centrifugation
Arm Type
Active Comparator
Arm Description
gradient-density centrifugation technique will be used when preparing sperm of male partner and IUI will be made with separated sperm
Intervention Type
Other
Intervention Name(s)
MicroFluidic Sperm Sorting Chips
Intervention Description
sperm selection of IUI treatment
Intervention Type
Other
Intervention Name(s)
Gradient-Density Centrifugation
Intervention Description
sperm selection of IUI treatment
Primary Outcome Measure Information:
Title
Compare microfluid chip and density-gradient methods in terms of IUI success
Description
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level
Time Frame
average of 6 months
Title
Compare microfluid chip and density-gradient methods in terms of embryo quality
Description
Embryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.
Time Frame
average of 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count >5 million) Volunteer Exclusion Criteria: Inadequate follicle development with medication Embryo does not have the appropriate quality for transfer Tubal pathology Total motile sperm count < 5 million Refuse to participate in research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pinar Ozcan, MD, Assoc Prof
Phone
+902124531700
Email
drpinarozcan@hotmail.com
Facility Information:
Facility Name
Bezmialem University
City
Istanbul
ZIP/Postal Code
34746
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinar Ozcan
First Name & Middle Initial & Last Name & Degree
Pinar Ozcan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31543253
Citation
Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
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
background

Learn more about this trial

Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles

We'll reach out to this number within 24 hrs