Intrauterine G-CSF Administration in RIF

Gurgan Clinic

Status: Completed

Conditions: Infertility

Treatments: Other: Saline; Drug: G-CSF

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03783208

20182

Details and patient eligibility

About

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

Full 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.

Enrollment: 157 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups, including a placebo group

G-CSF

Experimental group

Description:

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.

Treatment:

Drug: G-CSF

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Saline