Intrauterine G-CSF Administration in RIF

Intrauterine G-CSF Administration in Recurrent Implantation Failure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03783208

Acronym

G-CSF

Enrollment

157

Registered

2018-12-20

Start date

2018-11-01

Completion date

2018-12-20

Last updated

2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Endometrium, G-CSF, Recurrent implantation failure

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.

Interventions

DRUGG-CSF

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

OTHERSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Clinical pregnancy rate	1month	Gestational sac in USG per embryo transfer

Secondary

Measure	Time frame	Description
Endometrial thickness	1month	Measurement of endometrial thickness as millimeter

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026