Sequential Versus Single O2 Levels on Human Embryo Development

Embryo Culture Clinical Trial

Official title:

5% O2 or Lower is the Ideal Tension for Culturing Human Embryo Development From Day 3 Onward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630900
• Other study ID #: Ibnsina IVF-Oxygen
• Status: Completed
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: July 1, 2019

Study information

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

Clinical Trial Summary

Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: July 1, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• ICSI cycles undergoing their first ICSI attempt

Exclusion Criteria:

• ICSI cycles with a previous failure

Related Conditions & MeSH terms

• Embryo Culture

Intervention

Other:
• Sequential O2 Culture
We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ibn Sina Hospital	Banoon IVF Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Implantation rate	number of sacs with a heartbeat after week twelve of gestation	three months
Secondary	clinical and ongoing pregnancies	registered pregnancy with fetal heartbeat at week four after transfer and after week twelve of gestation	three months
Secondary	human embryo development in vitro		three months