- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144244
Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles
February 11, 2020 updated by: Bezmialem Vakif University
Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pinar Ozcan, MD, Assoc Prof
- Phone Number: +902124531700
- Email: drpinarozcan@hotmail.com
Study Locations
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-
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Istanbul, Turkey, 34746
- Recruiting
- Bezmialem University
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Contact:
- Pinar Ozcan
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Principal Investigator:
- Pinar Ozcan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MicroFluidic Sperm Sorting Chips
Sperm Sorting microfluidic chips will be used when preparing sperm of male partner and IUI will be made with separated sperm
|
sperm selection of IUI treatment
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Active Comparator: gradient-density centrifugation
gradient-density centrifugation technique will be used when preparing sperm of male partner and IUI will be made with separated sperm
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sperm selection of IUI treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare microfluid chip and density-gradient methods in terms of IUI success
Time Frame: average of 6 months
|
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level
|
average of 6 months
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Compare microfluid chip and density-gradient methods in terms of embryo quality
Time Frame: average of 6 months
|
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.
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average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2019
Primary Completion (Anticipated)
May 15, 2020
Study Completion (Anticipated)
July 15, 2020
Study Registration Dates
First Submitted
October 28, 2019
First Submitted That Met QC Criteria
October 28, 2019
First Posted (Actual)
October 30, 2019
Study Record Updates
Last Update Posted (Actual)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Microchip IUI study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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