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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778866
• Other study ID #: IbnSina-HEPES
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: August 5, 2019

Study information

• Verified date: August 2019
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1057
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• ICSI indicated cycles

Exclusion Criteria:

• severe medical illness

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Bicarbonate-buffered handling medium
The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.

Locations

Country	Name	City	State
Egypt	Banon Assiut	Assiut
Egypt	Qena Fertility Center	Qena
Egypt	IbnSina IVF Center	Sohag

Sponsors (3)

Lead Sponsor	Collaborator
Muhammad Fawzy	Banoon IVF Center, Quena IVF Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	viable neonate after 30 weeks of Gestation	40 weeks
Secondary	Clinical pregnancy rate	a positive heartbeat on ultrasound at = 7 weeks of gestation	12 weeks
Secondary	biochemical pregnancy rate	positive b-hCG at = 14 days following embryo transfer	two weeks
Secondary	embryo developmental rates	fertilized oocyte per injected ones and developed embryos per fertilized oocytes	6 days of culture
Secondary	Ongoing pregnancy rate	Continued pregnancy after week 12 of gestation	16 weeks