Adding Insulin to IVF Culture Media Significantly Improve Outcome

Sponsor

Ibn Sina Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02420171

Collaborator

Banon IVF Center Assiut, Egypt (Other)

360

Enrollment

Locations

Arms

Duration (Months)

180

Patients Per Site

16.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Adding insulin to In Vitro culture media	N/A

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: In Vitro culture media with insulin We will add insulin to the single step culture media to monitor the embryogenesis	Other: Adding insulin to In Vitro culture media We will add insulin for in vitro culture of human embryos
No Intervention: In Vitro culture media without insulin m The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one.

Arm

Intervention/Treatment

Active Comparator: In Vitro culture media with insulin

We will add insulin to the single step culture media to monitor the embryogenesis

Other: Adding insulin to In Vitro culture media

We will add insulin for in vitro culture of human embryos

No Intervention: In Vitro culture media without insulin m

The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one.

Outcome Measures

Primary Outcome Measures

clinical Pregnancy rate ( % ) [6 months]

Secondary Outcome Measures

Blastocyst rate ( % ) [6 months]
Blastocyst quality rate ( % ) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

normal responder
PCOS
Tubal factor infertility
mild asthenozoospermia

Exclusion Criteria:

patient over 40

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon IVF Center	Assiut		Egypt
2	Ibnsina IVF center	Sohag		Egypt

Sponsors and Collaborators

Ibn Sina Hospital
Banon IVF Center Assiut, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital

ClinicalTrials.gov Identifier:

NCT02420171

Other Study ID Numbers:

Ibnsina IVF center Sohag

First Posted:

Apr 17, 2015

Last Update Posted:

Jul 13, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital

In Vitro

embryo quality

Intracytoplasmic sperm injection

Additional relevant MeSH terms:

Infertility

Insulin

Study Results

No Results Posted as of Jul 13, 2016