Effect of Protein Concentration on Human Embryo Development (PCHED)

June 9, 2020 updated by: Muhammad Fawzy, Ibn Sina Hospital

Protein Concentration and Human Embryo Development

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1536

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Banon Assiut
      • Sohag, Egypt
        • IbnSina IVF Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Intracytoplasmic sperm injection cycles

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rate
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: 12 weeks
12 weeks
Implantation rate
Time Frame: 7 weeks
7 weeks
embryo development
Time Frame: two months
two months
Blastocyst Formation
Time Frame: two months
number of formed blastocyst per fertilized oocyte
two months
Clinical pregnancy rate
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibn Sina Hospital

Collaborators

Banon IVF Center Assiut, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Actual)

March 2, 2020

Study Completion (Actual)

March 2, 2020

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IbnSina IVFCenter-Protein

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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