Intrauterine G-CSF Administration in RIF | NCT03783208

Studies
Intrauterine G-CSF Administration in RIF

NCT03783208

Sponsor

Gurgan Clinic

Status

Completed

Last Update Posted

Dec 24, 2018Actual

Enrollment

157Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

G-CSF
Saline

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Dec 20, 2018Actual

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2018

Last Update Posted Date

Dec 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
G-CSF	Experimental	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
Control group	Placebo Comparator	Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group	Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-CSF	Drug	Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.	G-CSF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	Gestational sac in USG per embryo transfer	1month

Secondary Outcomes

Measure	Description	Time Frame
Endometrial thickness	Measurement of endometrial thickness as millimeter	1month

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Only female participants

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ziya Kalem, MD	Gurgan Clinic IVF and Women Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gurgan Clinic IVF and Women Health Center		Ankara	Cankaya	06640	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided