NCT03678584

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. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A 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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

September 17, 2018

Last Update Submit

May 5, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Oocyte Survival after ICSI

    Survived oocytes per MII injected

    two days

Secondary Outcomes (7)

  • Fertilization rate

    6 days of culture

  • Rate of top-quality embryo

    6 days of culture

  • blastocyst formation and quality

    6 days of culture

  • blastocyst utilization rate

    6 days of culture

  • clinical pregnancy rate

    7 weeks

  • +2 more secondary outcomes

Study Arms (2)

Handling Medium Supplemented with Chaetoglobosin A

EXPERIMENTAL
Other: Medium Supplemented with Chaetoglobosin A

handling Medium as it is.

NO INTERVENTION

Interventions

Medium Supplemented with Chaetoglobosin AOTHER

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

Handling Medium Supplemented with Chaetoglobosin A

Eligibility Criteria

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

You may qualify if:

  • All ICSI participants agreed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qena Fertility Center

Qina, Qena Governorate, 123456, Egypt

Location

Banon Assiut

Asyut, Egypt

Location

IbnSina IVF Center, IbnSina Hospital

Sohag, 12345, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

chaetoglobosins

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

May 2, 2019

Study Completion

May 3, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)