NCT03778866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,057

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

December 15, 2018

Last Update Submit

August 5, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    viable neonate after 30 weeks of Gestation

    40 weeks

Secondary Outcomes (4)

  • Clinical pregnancy rate

    12 weeks

  • biochemical pregnancy rate

    two weeks

  • embryo developmental rates

    6 days of culture

  • Ongoing pregnancy rate

    16 weeks

Study Arms (2)

Bicarbonate-buffered Medium

EXPERIMENTAL
Other: Bicarbonate-buffered handling medium

HEPES-MOPS-buffered Medium

NO INTERVENTION

Interventions

Bicarbonate-buffered handling mediumOTHER

The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.

Bicarbonate-buffered Medium

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ICSI indicated cycles

You may not qualify if:

  • severe medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qena Fertility Center

Qina, Qena Governorate, 123456, Egypt

Location

Banon Assiut

Asyut, Egypt

Location

IbnSina IVF Center

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 19, 2018

Study Start

January 15, 2019

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)