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Effect of Protein Concentration on Human Embryo Development (PCHED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630848
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Banon IVF Center Assiut, Egypt
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital

Study Description
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Brief Summary:
Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal.

Condition or disease Intervention/treatment Phase
Human Embryo Culture Other: Effect of Protein on Blastocyst Development Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Protein Concentration and Human Embryo Development
Actual Study Start Date : August 14, 2018
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : March 2, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: 10 mg/ml protein concentration in Embryo Culture Media Other: Effect of Protein on Blastocyst Development
Embryo Development Related to The Protein Concentration
No Intervention: 5 mg/ml protein concentration in Embryo Culture Media


Outcome Measures
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Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. embryo development [ Time Frame: two months ]
  2. Blastocyst Formation [ Time Frame: two months ]
    number of formed blastocyst per fertilized oocyte

  3. Clinical pregnancy rate [ Time Frame: 7 weeks ]
  4. Implantation rate [ Time Frame: 7 weeks ]
  5. Miscarriage rate [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intracytoplasmic sperm injection cycles

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630848


Locations
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Egypt
Banon Assiut
Assiut, Egypt
IbnSina IVF Center
Sohag, Egypt
Sponsors and Collaborators
Ibn Sina Hospital
Banon IVF Center Assiut, Egypt
More Information
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Responsible Party: Muhammad Fawzy, ivF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT03630848    
Other Study ID Numbers: IbnSina IVFCenter-Protein
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No