Trial | NCT03783208  Report issue

Title

Intrauterine G-CSF Administration in RIF
Intrauterine G-CSF Administration in Recurrent Implantation Failure

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    G-CSF ...

  • Study Participants

    157
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
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.
Study Started
Nov 01
2018
Primary Completion
Dec 20
2018
Study Completion
Dec 20
2018
Last Update
Dec 24
2018

Drug G-CSF

Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.

  • Other names: Leucostim

Other Saline

Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.

G-CSF Experimental

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.

Control group Placebo Comparator

Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group

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)
No Results Posted