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Adding Insulin to IVF Culture Media Significantly Improve Outcome

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Adding insulin to In Vitro culture media

About this trial

This is an interventional basic science trial for Infertility focused on measuring In Vitro, embryo quality, Intracytoplasmic sperm injection

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

normal responder
PCOS
Tubal factor infertility
mild asthenozoospermia

Exclusion Criteria:

patient over 40

Sites / Locations

Banon IVF Center
Ibnsina IVF center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

In Vitro culture media with insulin

In Vitro culture media without insulin m

Arm Description

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

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

Outcomes

Primary Outcome Measures

clinical Pregnancy rate ( % )

Secondary Outcome Measures

Blastocyst rate ( % )

Blastocyst quality rate ( % )

Full Information

NCT ID

NCT02420171

First Posted

April 14, 2015

Last Updated

July 11, 2016

Sponsor

Ibn Sina Hospital

Collaborators

Banon IVF Center Assiut, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT02420171

Brief Title

Adding Insulin to IVF Culture Media Significantly Improve Outcome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ibn Sina Hospital

Collaborators

Banon IVF Center Assiut, Egypt

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

In Vitro, embryo quality, Intracytoplasmic sperm injection

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

In Vitro culture media with insulin

Arm Type

Active Comparator

Arm Description

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

Arm Title

In Vitro culture media without insulin m

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Adding insulin to In Vitro culture media

Intervention Description

We will add insulin for in vitro culture of human embryos

Primary Outcome Measure Information:

Title

clinical Pregnancy rate ( % )

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Blastocyst rate ( % )

Time Frame

6 months

Title

Blastocyst quality rate ( % )

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: normal responder PCOS Tubal factor infertility mild asthenozoospermia Exclusion Criteria: patient over 40

Facility Information:

Facility Name

Banon IVF Center

City

Assiut

Country

Egypt

Facility Name

Ibnsina IVF center

City

Sohag

Country

Egypt

12. IPD Sharing Statement

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