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Intrauterine G-CSF Administration in RIF (G-CSF)

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

G-CSF

Saline

About this trial

This is an interventional supportive care trial for Infertility focused on measuring Endometrium, G-CSF, Recurrent implantation failure

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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)

Sites / Locations

Gurgan Clinic IVF and Women Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G-CSF

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Gestational sac in USG per embryo transfer

Secondary Outcome Measures

Endometrial thickness

Measurement of endometrial thickness as millimeter

Full Information

NCT ID

NCT03783208

First Posted

December 19, 2018

Last Updated

December 20, 2018

Sponsor

Gurgan Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03783208

Brief Title

Intrauterine G-CSF Administration in RIF

Acronym

G-CSF

Official Title

Intrauterine G-CSF Administration in Recurrent Implantation Failure

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

December 20, 2018 (Actual)

Study Completion Date

December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gurgan Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Endometrium, G-CSF, Recurrent implantation failure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

157 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G-CSF

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

G-CSF

Other Intervention Name(s)

Leucostim

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

Gestational sac in USG per embryo transfer

Time Frame

1month

Secondary Outcome Measure Information:

Title

Endometrial thickness

Description

Measurement of endometrial thickness as millimeter

Time Frame

1month

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Only female participants

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziya Kalem, MD

Organizational Affiliation

Gurgan Clinic IVF and Women Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gurgan Clinic IVF and Women Health Center

City

Ankara

State/Province

Cankaya

ZIP/Postal Code

06640

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Intrauterine G-CSF Administration in RIF

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