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Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)

Sponsor
Ibn Sina Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03678584
Collaborator
Banoon IVF Center (Other), Qena Fertility Center (Other)
300
Enrollment
3
Locations
2
Arms
7.2
Actual Duration (Months)
100
Patients Per Site
13.8
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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medium Supplemented with Chaetoglobosin A
 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:
Chaetoglobosin A Supplementation to ICSI Handling Medium
Actual Study Start Date :
Sep 25, 2018
Actual Primary Completion Date :
May 2, 2019
Actual Study Completion Date :
May 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Handling Medium Supplemented with Chaetoglobosin A

Other: Medium Supplemented with Chaetoglobosin A
A medium with in-house supplementation of Chaetoglobosin A 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 after ICSI [two days]

    Survived oocytes per MII injected

Secondary Outcome Measures

  1. Fertilization rate [6 days of culture]

  2. Rate of top-quality embryo [6 days of culture]

    Rate of top-quality embryo per fertilized oocytes

  3. blastocyst formation and quality [6 days of culture]

    Number of formed blastocyst and high-quality blastocyst per fertilized oocytes

  4. blastocyst utilization rate [6 days of culture]

    Number of transferred and vitrified embryos per fertilized oocytes

  5. clinical pregnancy rate [7 weeks]

    Number of pregnant women per recruited cycles

  6. Implantation rate [7 weeks]

    sacs with a heartbeat per embryo transferred

  7. 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 participants agreed
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
  • 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:
NCT03678584
Other Study ID Numbers:
  • IbnSinaIVF-ICSI-CA
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

Study Results

No Results Posted as of May 7, 2019