Adding Insulin to IVF Culture Media Significantly Improve Outcome

NCT ID: NCT02420171

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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In Vitro culture media with insulin

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

Group Type ACTIVE_COMPARATOR

Adding insulin to In Vitro culture media

Intervention Type OTHER

We will add insulin for in vitro culture of human embryos

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adding insulin to In Vitro culture media

We will add insulin for in vitro culture of human embryos

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* normal responder
* PCOS
* Tubal factor infertility
* mild asthenozoospermia

Exclusion Criteria

* patient over 40
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Banon IVF Center Assiut, Egypt

OTHER

Sponsor Role collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Fawzy

IVF Laboratory Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Banon IVF Center

Asyut, , Egypt

Site Status

Ibnsina IVF center

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ibnsina IVF center Sohag

Identifier Type: -

Identifier Source: org_study_id

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