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

• Sponsor: Muhammad Fawzy (Other)
• Overall Status: Completed
• CT.gov ID: NCT03778866
• Collaborator: Banoon IVF Center (Other), Quena IVF Center (Other)
• Enrollment: 1,057
• Locations: 3
• Arms: 2
• Actual Duration (Months): 6.6
• Patients Per Site: 352.3
• Patients Per Site Per Month: 53.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Bicarbonate-buffered handling medium	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1057 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI
• Actual Study Start Date: Jan 15, 2019
• Actual Primary Completion Date: Aug 5, 2019
• Actual Study Completion Date: Aug 5, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. live birth rate [40 weeks]

   viable neonate after 30 weeks of Gestation

Secondary Outcome Measures

1. Clinical pregnancy rate [12 weeks]

   a positive heartbeat on ultrasound at ≥ 7 weeks of gestation

2. biochemical pregnancy rate [two weeks]

   positive b-hCG at ≥ 14 days following embryo transfer

3. embryo developmental rates [6 days of culture]

   fertilized oocyte per injected ones and developed embryos per fertilized oocytes

4. Ongoing pregnancy rate [16 weeks]

   Continued pregnancy after week 12 of gestation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ICSI indicated cycles

Exclusion Criteria:

• severe medical illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon Assiut	Assiut		Egypt
2	Qena Fertility Center	Qena		Egypt	123456
3	IbnSina IVF Center	Sohag		Egypt

Sponsors and Collaborators

• Muhammad Fawzy
• Banoon IVF Center
• Quena IVF Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT03778866
• Other Study ID Numbers: IbnSina-HEPES
• First Posted: Dec 19, 2018
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Aug 7, 2019