NCT03999372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

June 25, 2019

Last Update Submit

January 22, 2020

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy rate (viable fetus)

    Up to 2 weeks

Secondary Outcomes (1)

  • Number of high quality embryos

    Within 48 hours of fertilization

Study Arms (2)

PICSI procedure

EXPERIMENTAL

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

ICSI procedure

ACTIVE COMPARATOR

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

Interventions

Hyaluronan binding systemBIOLOGICAL

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

PICSI procedure
ICSIOTHER

Normal ICSI procedure

ICSI procedure

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female 20-40 years
  • Male factor infertility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alazahr University

Cairo, Egypt

Location

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

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 23203216BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Eman Elgendy, MD

    International Islamic Centre for Population Studies and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
neither the participant nor the outcomes assessor know the assignment codes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 26, 2019

Study Start

July 5, 2019

Primary Completion

December 2, 2019

Study Completion

January 10, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

As per our local regulations

Locations

EG(2)