Gcsf Injection in Women With Repeated Implantaiton Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.

Detailed Description
-----------------
Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology. G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving: Immune tolerance The self-healing of oocyte chromosome abnormalities The adherence of the embryo The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.

Official Title
-----------------
Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial

Conditions
-----------------
Repeated Embryo Implantation Failure

Intervention / Treatment
-----------------
* Drug: Filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between the ages of 18 and 37 Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37. Negative repetitive implantation failure work up Exclusion Criteria: Renal failure or cardiac failure Chronic neutropenia Past or present cancer history Sickle cell anemia Lithium treatment Voluntary withdrawal from the study Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filgrastim<br>Injection Filgrastim 300 ug intravaginally during an IVF cycle or during an embryo transfer | Drug: Filgrastim<br>* The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.<br>* Other names: Neupogen;|
| Placebo Comparator: Sodium Chloride<br>Injection of 1 ml of Sodium Chloride intravaginally during an IVF cycle or during an embryo transfer cycle. | Drug: Filgrastim<br>* The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.<br>* Other names: Neupogen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of G-CSF | Measure dosage of G-CSF in the bloodstream on the day of oocyte retrieval and measure the implantation rate as well as pregnancy rate following the G-CSF injection | up to 3 years | 
| Pregnancy and Implantation | Measure the pregnancy and embryo implantation rate post G-CSF injection | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, IVF, Embryo transfer