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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03999372
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
ClinAmygate

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.

Condition or disease Intervention/treatment Phase
Infertility, Male Biological: Hyaluronan binding system Other: ICSI Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: neither the participant nor the outcomes assessor know the assignment codes
Primary Purpose: Treatment
Official Title: Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : December 2, 2019
Actual Study Completion Date : January 10, 2020


Arm Intervention/treatment
Experimental: PICSI procedure
PICSI procedure: PICSI dishes are conventional plastic culture dishes pre-prepared with 3 microdots of powdered. The powdered HA is re-hydrated by adding 5 μL droplets of fresh culture medium to each of the three microdots. A 2 μL droplet with suspension of treated spermatozoa is then connected with a pipette tip to these culture medium droplets. The PICSI dish is incubated under oil; within 5 minutes the bound spermatozoa are attached by their head to the surface of the HA-microdots and are spinning around their head. An ICSI injecting pipette is used to pick the best motile HA-bound sperm up and inject them one by one into an oocyte. The ICSI injecting pipette can be previously loaded with viscous medium (PVP or Sperm Slow) to facilitate sperm micromanipulation.
Biological: Hyaluronan binding system
Hyaluronan binding system for sperm selection for ICSI procedures (PICSI)

Active Comparator: ICSI procedure
ICSI procedure: following sperm preparation as described before, samples were incubated until time of injection. Each oocyte was injected with a single morphologically abnormal and immobilized in polyvinyl Pyrolidone (PVP) spermatozoon. Individual sperm subjected to ICSI was examined and evaluated. The injection procedure was carried out in a sterilized dish using holding pipette and injection needle. Intra cytoplasmic sperm injection was performed according to the protocol of Van Steirteghem.
Other: ICSI
Normal ICSI procedure




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: Up to 2 weeks ]
    Clinical pregnancy rate (viable fetus)


Secondary Outcome Measures :
  1. Number of high quality embryos [ Time Frame: Within 48 hours of fertilization ]
    Number of high quality embryos



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female 20-40 years
  • Male factor infertility

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999372


Locations
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Egypt
Alazahr University
Cairo, Egypt
Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University
Cairo, Egypt
Sponsors and Collaborators
ClinAmygate
Investigators
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Principal Investigator: Eman Elgendy, MD International Islamic Centre for Population Studies and Research
Publications:
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Responsible Party: ClinAmygate
ClinicalTrials.gov Identifier: NCT03999372    
Other Study ID Numbers: Clin-I-0201909
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As per our local regulations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents