NCT03678558

Brief Summary

Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte vitrification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 25, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

September 17, 2018

Last Update Submit

August 5, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • survival after thawing

    6 days of culture

Secondary Outcomes (5)

  • fertilization rate

    6 days of culture

  • Rates of blastocyst formation and quality

    6 days of culture

  • embryo utilisation rate

    6 days of culture

  • clinical pregnancy rate

    three months

  • ongoing pregnancy rate

    12 months

Study Arms (2)

Cytochalasin B supplemented vitrification medium

EXPERIMENTAL
Other: Cytochalasin B supplemented vitrification medium

Vitrification medium with no supplementation

NO INTERVENTION

Interventions

Cytochalasin B supplemented vitrification mediumOTHER

Vitrification of human oocyte in medium supplemented with Cytochalasin B

Cytochalasin B supplemented vitrification medium

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • indication for oocyte vitrification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IbnSina IVF Center, IbnSina Hospital

Sohag, 12345, 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, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

September 25, 2018

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)