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Completed

NCT Number: NCT03999372

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

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.

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Alazahr University, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female 20-40 years
  • Male factor infertility

Exclusion criteria

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

Treatment and study plan

Hyaluronan binding system

Biological

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

ICSI

Other

Normal ICSI procedure

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: Up to 2 weeks

    Clinical pregnancy rate (viable fetus)

Secondary outcomes

  1. Number of high quality embryos

    Time frame: Within 48 hours of fertilization

    Number of high quality embryos

Sponsors and collaborators

Lead sponsor

ClinAmygate

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 26, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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