NCT02896777

Triple-arm pH Comparison

Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,273 (actual)
• Sponsor: Ibn Sina Hospital · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.

Detailed description

In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos.

Conditions

• In Vitro Fertilisation Outcome

Interventions

Type	Name	Description
OTHER	Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6	Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.
OTHER	Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6	Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.
OTHER	Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6	Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6

Timeline

• Start date: 2020-06-13
• Primary completion: 2023-04-27
• Completion: 2023-08-11
• First posted: 2016-09-12
• Last updated: 2023-08-21

Locations

6 sites across 1 country: Egypt