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

Infertility, Male Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144244
• Other study ID #: Microchip IUI study
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Infertility Unexplained
• Infertility, Male

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