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Clinical Trials/NCT03999372
NCT03999372
Completed
Phase 4

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

ClinAmygate2 sites in 1 country300 target enrollmentJuly 5, 2019

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Infertility, Male
Sponsor
ClinAmygate
Enrollment
300
Locations
2
Primary Endpoint
Clinical pregnancy rate
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 5, 2019
End Date
January 10, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
ClinAmygate
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female 20-40 years
  • Male factor infertility

Exclusion Criteria

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

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: Up to 2 weeks

Clinical pregnancy rate (viable fetus)

Secondary Outcomes

  • Number of high quality embryos(Within 48 hours of fertilization)

Study Sites (2)

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