NCT03663634

Brief Summary

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
987

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

September 6, 2018

Last Update Submit

August 5, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • oocyte survival rate

    number of survived oocyte after intracytoplasmic sperm injection

    6 days of culture

Secondary Outcomes (5)

  • fertilization rate

    6 days of culture

  • blastocyst formation rate

    6 days of culture

  • embryo utilization rate

    6 days of culture

  • clinical pregnancy rate

    three months

  • ongoing pregnancy rate

    four months

Study Arms (2)

Handling Medium Supplemented with Cytochalasin B

EXPERIMENTAL
Other: Cytochalasin B use in ICSI handling medium

Handling Medium as it is.

NO INTERVENTION

Interventions

Cytochalasin B use in ICSI handling mediumOTHER

A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate

Handling Medium Supplemented with Cytochalasin B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All ICSI candidates patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IbnSina IVF Center

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 10, 2018

Study Start

September 16, 2018

Primary Completion

July 20, 2019

Study Completion

August 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)