CClinicalTrials.gg
CompletedNCT03778866Updated Aug 7, 2019

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

An interventional study of Bicarbonate-buffered handling medium in Infertility, sponsored by Muhammad Fawzy. Completed at 3 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-07.

Sponsored by Muhammad Fawzy · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,057
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 1,057 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

This is the only study on the registry with Muhammad Fawzy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • ICSI indicated cycles

Exclusion criteria

Exclusion Criteria:

  • severe medical illness
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,057 participants (actual)

Study arms

  • Experimental
    Bicarbonate-buffered Medium

    Other: Bicarbonate-buffered handling medium

  • No intervention
    HEPES-MOPS-buffered Medium

Interventions

  • OtherBicarbonate-buffered handling medium

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

06

What researchers measure

Primary outcomes

  1. live birth rate

    viable neonate after 30 weeks of Gestation

    Time frame: 40 weeks

Secondary outcomes

  1. Clinical pregnancy rate

    a positive heartbeat on ultrasound at ≥ 7 weeks of gestation

    Time frame: 12 weeks

  2. biochemical pregnancy rate

    positive b-hCG at ≥ 14 days following embryo transfer

    Time frame: two weeks

  3. embryo developmental rates

    fertilized oocyte per injected ones and developed embryos per fertilized oocytes

    Time frame: 6 days of culture

  4. Ongoing pregnancy rate

    Continued pregnancy after week 12 of gestation

    Time frame: 16 weeks

07

Study locations

3 sites
  • Banon Assiut
    Assiut, Egypt
  • Qena Fertility Center
    Qena, 123456, Egypt
  • IbnSina IVF Center
    Sohag, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03778866
Lead sponsor
Muhammad Fawzy
Collaborators
Banoon IVF Center, Quena IVF Center
Responsible party
Muhammad Fawzy (IVF Lab Director, Ibn Sina Hospital) — Sponsor-investigator
First posted
Dec 19, 2018
Start date
Jan 15, 2019
Primary completion
Aug 5, 2019
Completion
Aug 5, 2019
Last update
Aug 7, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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