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

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ClinicalTrials.gov Identifier: NCT03783208
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gurgan Clinic

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 20, 2018

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 Name: 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.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 1month ]
    Gestational sac in USG per embryo transfer


Secondary Outcome Measures :
  1. Endometrial thickness [ Time Frame: 1month ]
    Measurement of endometrial thickness as millimeter



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female participants
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783208


Locations
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Turkey
Gurgan Clinic IVF and Women Health Center
Ankara, Cankaya, Turkey, 06640
Sponsors and Collaborators
Gurgan Clinic
Investigators
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Principal Investigator: Ziya Kalem, MD Gurgan Clinic IVF and Women Health Center

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Responsible Party: Gurgan Clinic
ClinicalTrials.gov Identifier: NCT03783208     History of Changes
Other Study ID Numbers: 20182
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gurgan Clinic:
Endometrium
G-CSF
Recurrent implantation failure

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs