Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)

Infertility, Male Clinical Trial

Official title:

Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999372
• Other study ID #: Clin-I-0201909
• Status: Completed
• Phase: Phase 4
• Start date: July 5, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2020
• Source: ClinAmygate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In vitro sperm selection for ICSI is important as it has a direct influence on the paternal contribution of preimplantation embryogenesis. Various laboratory tests were developed to assess the functions of the spermatozoa. Among them, only the tests for sperm DNA fragmentation, hyperactivation of the spermatozoa and the hyaluronan-binding ability are simple and fast.

Description:

In vitro sperm selection for ICSI is important as it has a direct influence on the paternal contribution of preimplantation embryogenesis. Men with oligozoospermia who require ICSI often demonstrate compromised DNA integrity and increased chromosomal aberrations of the sperms in their semen. Studies have shown that embryos resulting from ICSI in those men have higher risk of sex chromosome disomies, chromosomal aneuploidies, de novo numerical chromosomal aberrations and cytogenetically detectable structural chromosomal aberrations. Although the main candidates for ICSI are oligozoospermic men, there is an increase in the use of ICSI, therefore, more couples are potentially exposed to those potential risks.

Various laboratory tests were developed to assess the functions of the spermatozoa. Among them, only the tests for sperm DNA fragmentation (Halosperm), hyperactivation of the spermatozoa and the hyaluronan-binding ability (HBA) are simple and fast enough to allow the same semen sample tested to be used for oocytes' insemination. Spermatozoa that are fail to bind to hyaluronan have many aspects of immaturity. They retain histones in the sperm nucleus, cytoplasm on the sperm neck, and have higher aberrant sperm head morphology, in addition to, lower genomic integrity. It has also been shown that sperm DNA fragmentation is associated with male factor of infertility, correlating with the morphology and motility of spermatozoa.

The aim of the present study is to carry out a comparative analysis between two groups:

Hyaluronan binding system for sperm selection for ICSI procedures and another group of conventional morphology sperm selection (ICSI-PVP), both in cycles with only male infertility factor. The evaluated parameters were semen quality, fertilization and cleavage rates, chemical and clinical pregnancy, and miscarriage rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 10, 2020
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Female 20-40 years

• Male factor infertility

Exclusion Criteria:

• Other factor of infertility (tubal, uterine, ... etc)

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Biological:
• Hyaluronan binding system
Hyaluronan binding system for sperm selection for ICSI procedures (PICSI)

Other:
• ICSI
Normal ICSI procedure

Locations

Country	Name	City	State
Egypt	Alazahr University	Cairo
Egypt	Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
ClinAmygate

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Worrilow KC, Eid S, Woodhouse D, Perloe M, Smith S, Witmyer J, Ivani K, Khoury C, Ball GD, Elliot T, Lieberman J. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial. Hum Reprod. 2013 Feb;28(2):306-14. doi: 10.1093/humrep/des417. Epub 2012 Nov 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Clinical pregnancy rate (viable fetus)	Up to 2 weeks
Secondary	Number of high quality embryos	Number of high quality embryos	Within 48 hours of fertilization