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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04144244
Other study ID # Microchip IUI study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date July 15, 2020

Study information

Verified date February 2020
Source Bezmialem Vakif University
Contact Pinar Ozcan, MD, Assoc Prof
Phone +902124531700
Email drpinarozcan@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 176
Est. completion date July 15, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
MicroFluidic Sperm Sorting Chips
sperm selection of IUI treatment
Gradient-Density Centrifugation
sperm selection of IUI treatment

Locations

Country Name City State
Turkey Bezmialem University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 average of 6 months
Primary 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. average of 6 months
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