Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate

August 5, 2019 updated by: Muhammad Fawzy

Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI

The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1057

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
      • Qena, Egypt, 123456
        • Qena Fertility Center
      • 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:

  • ICSI indicated cycles

Exclusion Criteria:

  • severe medical illness

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bicarbonate-buffered Medium
Other: Bicarbonate-buffered handling medium
The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.
No Intervention: HEPES-MOPS-buffered Medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 40 weeks
viable neonate after 30 weeks of Gestation
40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 12 weeks
a positive heartbeat on ultrasound at ≥ 7 weeks of gestation
12 weeks
biochemical pregnancy rate
Time Frame: two weeks
positive b-hCG at ≥ 14 days following embryo transfer
two weeks
embryo developmental rates
Time Frame: 6 days of culture
fertilized oocyte per injected ones and developed embryos per fertilized oocytes
6 days of culture
Ongoing pregnancy rate
Time Frame: 16 weeks
Continued pregnancy after week 12 of gestation
16 weeks

Collaborators and Investigators

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

Sponsor

Muhammad Fawzy

Collaborators

Banoon IVF Center
Quena IVF Center

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)

January 15, 2019

Primary Completion (Actual)

August 5, 2019

Study Completion (Actual)

August 5, 2019

Study Registration Dates

First Submitted

December 15, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IbnSina-HEPES

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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