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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02420171
Other study ID # Ibnsina IVF center Sohag
Secondary ID
Status Completed
Phase N/A
First received April 14, 2015
Last updated July 11, 2016
Start date January 2015
Est. completion date December 2015

Study information

Verified date July 2016
Source Ibn Sina Hospital
Contact n/a
Is FDA regulated No
Health authority Egypt: Banon IVF center
Study type Interventional

Clinical Trial Summary

Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.


Description:

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- normal responder

- PCOS

- Tubal factor infertility

- mild asthenozoospermia

Exclusion Criteria:

- patient over 40

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Adding insulin to In Vitro culture media
We will add insulin for in vitro culture of human embryos

Locations

Country Name City State
Egypt Banon IVF Center Assiut
Egypt Ibnsina IVF center Sohag

Sponsors (2)

Lead Sponsor Collaborator
Ibn Sina Hospital Banon IVF Center Assiut, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical Pregnancy rate ( % ) 6 months Yes
Secondary Blastocyst rate ( % ) 6 months Yes
Secondary Blastocyst quality rate ( % ) 6 months Yes
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