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

Phase 1

• Conditions: Infertility
• Interventions: Drug: neupogen administration for women with recurrent IVF failure

• Registration Number: NCT01315470
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24
• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neupogen	neupogen administration for women with recurrent IVF failure	-

Primary Outcome Measures

Name	Time	Method
pregnancy rate	18 months

Secondary Outcome Measures

Name	Time	Method
endometrial thickness during IVF treatment	18 months
endometrial thickness	18 months

Trial Locations

Locations (1)

Hadassah Ein Karem; 🇮🇱 Jerusalem, Israel