Intrauterine G-CSF Administration in RIF

NCT ID: NCT03783208

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2018-12-20

Brief Summary

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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

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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.

Conditions

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Infertility

Keywords

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Endometrium G-CSF Recurrent implantation failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

G-CSF

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

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

Interventions

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G-CSF

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

Intervention Type DRUG

Saline

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

Intervention Type OTHER

Other Intervention Names

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Leucostim

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gurgan Clinic

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziya Kalem, MD

Role: PRINCIPAL_INVESTIGATOR

Gurgan Clinic IVF and Women Health Center

Locations

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Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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20182

Identifier Type: -

Identifier Source: org_study_id