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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03778866
Enrollment
1057
Registered
2018-12-19
Start date
2019-01-15
Completion date
2019-08-05
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

OTHERBicarbonate-buffered handling medium

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

Sponsors

Banoon IVF Center
CollaboratorOTHER
Quena IVF Center
CollaboratorUNKNOWN
Muhammad Fawzy
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* ICSI indicated cycles

Exclusion criteria

* severe medical illness

Design outcomes

Primary

MeasureTime frameDescription
live birth rate40 weeksviable neonate after 30 weeks of Gestation

Secondary

MeasureTime frameDescription
Clinical pregnancy rate12 weeksa positive heartbeat on ultrasound at ≥ 7 weeks of gestation
biochemical pregnancy ratetwo weekspositive b-hCG at ≥ 14 days following embryo transfer
embryo developmental rates6 days of culturefertilized oocyte per injected ones and developed embryos per fertilized oocytes
Ongoing pregnancy rate16 weeksContinued pregnancy after week 12 of gestation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026