Intrauterine G-CSF Administration in RIF

Gurgan Clinic157 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

157

Conditions

Infertility

Interventions

G-CSFDRUG

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

SalineOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

Clinical pregnancy rate

Gestational sac in USG per embryo transfer

Time frame: 1month

Secondary Outcomes

Endometrial thickness

Measurement of endometrial thickness as millimeter

Time frame: 1month

Data from ClinicalTrials.gov

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