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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03999372
Enrollment
300
Registered
2019-06-26
Start date
2019-07-05
Completion date
2020-01-10
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male

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.

Interventions

BIOLOGICALHyaluronan binding system

Hyaluronan binding system for sperm selection for ICSI procedures (PICSI)

OTHERICSI

Normal ICSI procedure

Sponsors

ClinAmygate
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

neither the participant nor the outcomes assessor know the assignment codes

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Female 20-40 years * Male factor infertility

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rateUp to 2 weeksClinical pregnancy rate (viable fetus)

Secondary

MeasureTime frameDescription
Number of high quality embryosWithin 48 hours of fertilizationNumber of high quality embryos

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026