Intrauterine G-CSF Administration in RIF

Sponsor

Gurgan Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03783208

Collaborator

(none)

157

Enrollment

Location

Arms

1.6

Actual Duration (Months)

97.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: G-CSF Other: Saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

157 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Intrauterine G-CSF Administration in Recurrent Implantation Failure

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Dec 20, 2018

Actual Study Completion Date :

Dec 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: G-CSF Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter. Other Names: Leucostim
Placebo Comparator: Control group Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group	Other: Saline Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.

Arm

Intervention/Treatment

Experimental: 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.

Drug: G-CSF

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

Other Names:

Leucostim

Placebo Comparator: Control group

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

Other: Saline

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

Outcome Measures

Primary Outcome Measures

Clinical pregnancy rate [1month]
Gestational sac in USG per embryo transfer

Secondary Outcome Measures

Endometrial thickness [1month]
Measurement of endometrial thickness as millimeter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gurgan Clinic IVF and Women Health Center	Ankara	Cankaya	Turkey	06640

Sponsors and Collaborators

Gurgan Clinic

Investigators

Principal Investigator: Ziya Kalem, MD, Gurgan Clinic IVF and Women Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gurgan Clinic

ClinicalTrials.gov Identifier:

NCT03783208

Other Study ID Numbers:

20182

First Posted:

Dec 20, 2018

Last Update Posted:

Dec 24, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gurgan Clinic

Endometrium

G-CSF

Recurrent implantation failure

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Dec 24, 2018