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

March 23, 2011 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Ein Karem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neupogen
Drug: neupogen administration for women with recurrent IVF failure
neupogen 300 mcg - twice
Other Names:
  • filgrastim
  • GCSF injection
No Intervention: no intervantion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
endometrial thickness during IVF treatment
Time Frame: 18 months
18 months
endometrial thickness
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: einat zivi, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCSF-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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