Clincosm LogoSign in Get a demo

Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)

Sponsor
Ibn Sina Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03678597
Collaborator
(none)
300
Enrollment
3
Locations
2
Arms
6.1
Actual Duration (Months)
100
Patients Per Site
16.4
Patients Per Site Per Month

Study Details

Study Description

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. Latrunculin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

Condition or Disease Intervention/Treatment Phase
  • Other: Medium Supplemented with Latrunculin B
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Latrunculin B Supplementation to ICSI Handling Medium
Actual Study Start Date :
Sep 25, 2018
Actual Primary Completion Date :
Mar 25, 2019
Actual Study Completion Date :
Mar 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Handling Medium Supplemented with Latrunculin B

Other: Medium Supplemented with Latrunculin B
A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate
No Intervention: handling Medium as it is.

Outcome Measures

Primary Outcome Measures

  1. oocyte survival rate after ICSI [6 days of culture]

Secondary Outcome Measures

  1. Fertilisation rate [6 days of culture]

  2. Rates of blastocyst formation and quality [6 days of culture]

    Number of formed and high-quality blastocysts per fertilized oocytes

  3. Clinical pregnancy rate [three months]

  4. Implantation rate [7 weeks]

  5. Ongoing pregnancy rate [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All ICSI cycles
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banon Assiut Assiut Egypt
2 Qena Fertility Center Qena Egypt 123456
3 IbnSina IVF Center, IbnSina Hospital Sohag Egypt 12345

Sponsors and Collaborators

  • Ibn Sina Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier:
NCT03678597
Other Study ID Numbers:
  • IbnSinaIVF-ICSI-LB
First Posted:
Sep 19, 2018
Last Update Posted:
May 7, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of May 7, 2019