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Handling Medium for ICSI With Ionomycin and Latrunculin A

Sponsor
Ibn Sina Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03678610
Collaborator
Banoon IVF Center (Other), Qena Fertility Center (Other)
700
Enrollment
3
Locations
2
Arms
7.2
Actual Duration (Months)
233.3
Patients Per Site
32.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using Latrunculin A and Ionomycin would improve the outcome of ICSI if the handling medium during the ICSI procedure has them.

Condition or Disease Intervention/Treatment Phase
  • Other: Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Latrunculin A and Ionomycin as a Handling Medium for ICSI
Actual Study Start Date :
Sep 25, 2018
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICSI medium supplemented with Ionomycin and Latrunculin A

Other: Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A
Ionomycin and Latrunculin A would activate oocyte during ICSI along with cytoskeleton stabilization for a favourable outcomes
No Intervention: ICSI medium as it is

Outcome Measures

Primary Outcome Measures

  1. Fertilization rate [6 days of culture]

Secondary Outcome Measures

  1. Rates of Blastocyst formation and quality [6 days of culture]

    Number of formed blastocysts and blastocysts with good-quality per fertilized oocytes

  2. embryo utilization rate [6 days of culture]

  3. clinical pregnancy rate [three months]

  4. 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:
  • indication for ICSI
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 Sohag Egypt

Sponsors and Collaborators

  • Ibn Sina Hospital
  • Banoon IVF Center
  • Qena Fertility Center

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:
NCT03678610
Other Study ID Numbers:
  • Ibnsina-ICSI-ionomycin-LA
First Posted:
Sep 19, 2018
Last Update Posted:
May 7, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Ionomycin

Study Results

No Results Posted as of May 7, 2019