Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)

Sponsor

Ibn Sina Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02422134

Collaborator

Banon IVF Center Assiut, Egypt (Other)

400

Enrollment

Locations

Arms

Duration (Months)

200

Patients Per Site

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Cytokine group	N/A

Detailed Description

The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cytokine plus Hyalurinan embryo transfer arm To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.	Other: Cytokine group Testing the efficacy of adding Cytokine to embryo transfer medium
No Intervention: Hyalurinan embryo transfer group To transfer the embryos using a Hyaluronan enriched medium only

Arm

Intervention/Treatment

Active Comparator: Cytokine plus Hyalurinan embryo transfer arm

To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.

Other: Cytokine group

Testing the efficacy of adding Cytokine to embryo transfer medium

No Intervention: Hyalurinan embryo transfer group

To transfer the embryos using a Hyaluronan enriched medium only

Outcome Measures

Primary Outcome Measures

Pregnancy rate ( % ) [9 months]

Secondary Outcome Measures

Implantation rate ( % ) [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

all patients

Exclusion Criteria:

above 40 years old

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 Lab Director, Ibn Sina Hospital

ClinicalTrials.gov Identifier:

NCT02422134

Other Study ID Numbers:

Ibnsina IVF Sohag

First Posted:

Apr 21, 2015

Last Update Posted:

Jun 29, 2016

Last Verified:

Jun 1, 2016

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

Pregnancy

implantation

Cytokine

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jun 29, 2016