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

Infertility Clinical Trial

Official title:

Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01315470
• Other study ID #: GCSF-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1
• First received: March 14, 2011
• Last updated: March 23, 2011
• Start date: June 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2011
• Source: Hadassah Medical Organization
• Contact: einat zivi, MD
• Phone: 0508573943
• Email: zivi_e[@]hotmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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-

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• neupogen administration for women with recurrent IVF failure
neupogen 300 mcg - twice

Locations

Country	Name	City	State
Israel	Hadassah Ein Karem	Jerusalem
Israel	Hadassah Ein Karem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate		18 months	Yes
Secondary	endometrial thickness during IVF treatment		18 months	No
Secondary	endometrial thickness		18 months	Yes

External Links

•   3. GM-CSF regulation of embryo development and pregnancy. Robertson SA. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):287-98
•   3. GM-CSF regulation of embryo development and pregnancy. Robertson SA. Cytokine Growth Factor Rev. 2007 Jun-Aug;18(3-4):287-98