Intrauterine G-CSF Administration in RIF

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Saline; Drug: G-CSF

• Registration Number: NCT03783208
• Lead Sponsor: Gurgan Clinic

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.

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Study First Posted: 2018-12-20
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group
G-CSF	G-CSF	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.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	1month	Gestational sac in USG per embryo transfer

Secondary Outcome Measures

Name	Time	Method
Endometrial thickness	1month	Measurement of endometrial thickness as millimeter

Trial Locations

Locations (1)

Gurgan Clinic IVF and Women Health Center; 🇹🇷 Ankara, Cankaya, Turkey