Trials Sponsors Conditions Drugs Pricing

Conditions

Infertility, Male Intracytoplasmic Sperm Injection

Keywords

Intracytoplasmic sperm injection (ICSI)zona pellucida (ZP)natural sperm selectionSperm-oocyte interactionZP-bound sperm

Outcome Measures

Primary Outcomes (5)

fertilization rate
percentage of transformation of micro injected oocytes into two pronuclei
17-18 hours post ICSI
cleavage rate
percentage of cleavage of fertilized oocytes into 2-4 cell embryos
44 ± 1 h post ICSI
high-quality cleaved embryos rate
percentage of total number of high-quality day-3 embryos by total number of cleaved embryos
68 ± 1 h post ICSI
blastocyst formation rate
percentage of total number of embryos transformed into blastocysts by total number of cleaved embryos
107.9-112.9 hours after ICSI

Study Arms (2)

control

NO INTERVENTION

Oocytes of the control group were injected with conventionally selected spermatozoa based on sperm morphology and motility after being processed density gradient centrifugation

treatment

EXPERIMENTAL

ZP-bound sperm were selected from the surface of the immature oocytes through the use of a microneedle (Sunlight Medical, Jacksonville, FL, USA) and transferred in a 10 % polyvinylpyrrolidone (PVP) solution (SAGE, USA), immobilized, and then used to inject sibling MII oocytes

Other: ZP-binding

Interventions

ZP-bindingOther

The ZP is selective with regard to binding and can bind to normally functioning sperm, especially those with a normal acrosomal region

treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 38 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Couples must be diagnosed with infertility and undergoing ICSI cycle.
The age range for all female subjects must be between 21 and 38 years old, and their male partners must be older than 24 years old and above 50 years old.

Sponsors & Collaborators

Al-Azhar University
Otherlead

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

Nehal A Abu Elnaga, PhD
Al-Azhar University
STUDY DIRECTOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Embryologist

Study Record Dates

First Submitted

December 11, 2022

First Posted

February 13, 2023

Study Start

March 5, 2021

Actual (reported)

Outcome of Using Sperm Bound to the Zona Pellucida of Immature Oocytes for Intracytoplasmic Sperm Injection (ICSI)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

control

treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

control

treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations