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

Primary Purpose

Infertility, Male

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Hyaluronan binding system
ICSI
Sponsored by
ClinAmygate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female 20-40 years
  • Male factor infertility

Exclusion Criteria:

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

Sites / Locations

  • Alazahr University
  • Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PICSI procedure

ICSI procedure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Clinical pregnancy rate (viable fetus)

Secondary Outcome Measures

Number of high quality embryos
Number of high quality embryos

Full Information

First Posted
June 25, 2019
Last Updated
January 22, 2020
Sponsor
ClinAmygate
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1. Study Identification

Unique Protocol Identification Number
NCT03999372
Brief Title
Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)
Official Title
Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
neither the participant nor the outcomes assessor know the assignment codes
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PICSI procedure
Arm Type
Experimental
Arm Description
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.
Arm Title
ICSI procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Hyaluronan binding system
Intervention Description
Hyaluronan binding system for sperm selection for ICSI procedures (PICSI)
Intervention Type
Other
Intervention Name(s)
ICSI
Intervention Description
Normal ICSI procedure
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Clinical pregnancy rate (viable fetus)
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Number of high quality embryos
Description
Number of high quality embryos
Time Frame
Within 48 hours of fertilization

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female 20-40 years Male factor infertility Exclusion Criteria: Other factor of infertility (tubal, uterine, ... etc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Elgendy, MD
Organizational Affiliation
International Islamic Centre for Population Studies and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alazahr University
City
Cairo
Country
Egypt
Facility Name
Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
As per our local regulations
Citations:
PubMed Identifier
23203216
Citation
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.
Results Reference
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Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)

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