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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01315470
First received: March 14, 2011
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Drug: neupogen administration for women with recurrent IVF failure
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • endometrial thickness during IVF treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • endometrial thickness [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neupogen Drug: neupogen administration for women with recurrent IVF failure
neupogen 300 mcg - twice
Other Names:
  • GCSF injection
  • filgrastim
No Intervention: no intervantion

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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-
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315470

Contacts
Contact: einat zivi, MD 0508573943 zivi_e@hotmail.com

Locations
Israel
Hadassah Ein Karem Not yet recruiting
Jerusalem, Israel
Contact: einat zivi, MD     0508573943     zivi_e@hotmail.com    
Principal Investigator: einat zivi, MD            
Hadassah Ein Karem Not yet recruiting
Jerusalem, Israel
Contact: einat zivi, md         zivi_e@hotmail.com    
Principal Investigator: einat zivi, md            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: einat zivi, MD
  More Information

Additional Information:
3. GM-CSF regulation of embryo development and pregnancy. Robertson SA. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):287-98  This link exits the ClinicalTrials.gov site
3. GM-CSF regulation of embryo development and pregnancy. Robertson SA. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):287-98  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Einat Zivi, organizational affiliation
ClinicalTrials.gov Identifier: NCT01315470     History of Changes
Other Study ID Numbers: GCSF-HMO-CTIL
Study First Received: March 14, 2011
Last Updated: March 23, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
improving pregnancy rate and endometrial thickness

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Lenograstim
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013