Use of GM-CSF Treatment in Recurrent Implantation Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.

Detailed Description
-----------------
The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts. The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.

Official Title
-----------------
Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles

Conditions
-----------------
Women With Recurrent Implantation Failure in IVF

Intervention / Treatment
-----------------
* Drug: GM-CSF group
* Drug: CONTROL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 50 years old or less with three or more previous egg donation cycles failed, with a total of at least 4 blastocysts replaced in uterus Exclusion Criteria: chromosomal defects in the patients, metabolic diseases (diabetes etc.) genetic diseases (thalassemia, cystic fibrosis, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CONTROL<br>patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test | Drug: CONTROL<br>* saline infusion every day from the day of embryo transfer through the day of beta HCG test<br>* Other names: SALINE INFUSION;|
| Experimental: GM-CSF group<br>patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test | Drug: GM-CSF group<br>* 30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test<br>* Other names: GM-CSF;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy outcome | The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | number of embryos implanted | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GM-CSF, IVF failure,pregnancy