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Completed

NCT Number: NCT03783208

Intrauterine G-CSF Administration in RIF

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, 06640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

G-CSF

Drug

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

Other names: Leucostim

Saline

Other

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

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 1month

    Gestational sac in USG per embryo transfer

Secondary outcomes

  1. Endometrial thickness

    Time frame: 1month

    Measurement of endometrial thickness as millimeter

Sponsors and collaborators

Lead sponsor

Gurgan Clinic

Network

Registry information

Official study title

Intrauterine G-CSF Administration in Recurrent Implantation Failure

Acronym: G-CSF

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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