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Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
neupogen administration for women with recurrent IVF failure
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring improving pregnancy rate and endometrial thickness

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. women after 5 failures in IVF cycles with cause unknown.
  2. women after 5 failures in IVF due to thin endometrium (<6 mm) and unresponsive to estrogen supplements.

Exclusion Criteria:

  1. history of hematology disease
  2. allergy to GCSF
  3. neutrophilia
  4. severe lower back pain
  5. liver dysfunction
  6. hyperuricemia
  7. a recent febrile disease or pneumonia
  8. rheumatoid arthritis 9. sickle cell disease-

Sites / Locations

  • Hadassah Ein Karem
  • Hadassah Ein Karem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

neupogen

no intervantion

Arm Description

Outcomes

Primary Outcome Measures

pregnancy rate

Secondary Outcome Measures

endometrial thickness during IVF treatment
endometrial thickness

Full Information

First Posted
March 14, 2011
Last Updated
March 23, 2011
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01315470
Brief Title
Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients
Official Title
Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.
Detailed Description
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of repeated implantation failure (5 cycles) in IVF patient with cause unknown or due to thin endometrium. we intend to treat with GCSF during the IVF cycle if thin endometrium (<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
improving pregnancy rate and endometrial thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neupogen
Arm Type
Experimental
Arm Title
no intervantion
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
neupogen administration for women with recurrent IVF failure
Other Intervention Name(s)
GCSF injection, filgrastim
Intervention Description
neupogen 300 mcg - twice
Primary Outcome Measure Information:
Title
pregnancy rate
Time Frame
18 months
Secondary Outcome Measure Information:
Title
endometrial thickness during IVF treatment
Time Frame
18 months
Title
endometrial thickness
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women after 5 failures in IVF cycles with cause unknown. women after 5 failures in IVF due to thin endometrium (<6 mm) and unresponsive to estrogen supplements. Exclusion Criteria: history of hematology disease allergy to GCSF neutrophilia severe lower back pain liver dysfunction hyperuricemia a recent febrile disease or pneumonia rheumatoid arthritis 9. sickle cell disease-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
einat zivi, MD
Phone
0508573943
Email
zivi_e@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
einat zivi, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Ein Karem
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
einat zivi, MD
Phone
0508573943
Email
zivi_e@hotmail.com
First Name & Middle Initial & Last Name & Degree
einat zivi, MD
Facility Name
Hadassah Ein Karem
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
einat zivi, md
Email
zivi_e@hotmail.com
First Name & Middle Initial & Last Name & Degree
einat zivi, md

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17512774
Description
3. GM-CSF regulation of embryo development and pregnancy. Robertson SA. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):287-98

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Use of Granulocyte Colony-stimulating Factor for the Treatment of Recurrent Implantation Failure in IVF Patients

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