Intrauterine G-CSF Administration in RIF

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group

Detailed Description
-----------------
This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.

Official Title
-----------------
Intrauterine G-CSF Administration in Recurrent Implantation Failure

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: G-CSF
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women under the age of 40 who met the RIF definition Follicle-stimulating hormone (FSH) levels were <15 IU/mL Exclusion Criteria: Patients with congenital uterine anomalies Patients with Asherman's syndrome Patients with uterine cavity distorted by myoma or endometrial polyps Patients with confirmed endometriosis or endometrioma Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-CSF<br>Patients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter. | Drug: G-CSF<br>* Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.<br>* Other names: Leucostim;|
| Placebo Comparator: Control group<br>Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group | Other: Saline<br>* Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Gestational sac in USG per embryo transfer | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial thickness | Measurement of endometrial thickness as millimeter | 1month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrium, G-CSF, Recurrent implantation failure