Intrauterine G-CSF Administration in RIF

NCT03783208 | Completed

• 1 other identifier: 20182
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Keywords

Endometrium; G-CSF; Recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Gestational sac in USG per embryo transfer

  1month

Secondary Outcomes (1)

• Endometrial thickness

  1month

Study Arms (2)

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

G-CSF DRUG

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

Also known as: Leucostim

G-CSF

Saline OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only female participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women under the age of 40 who met the RIF definition
• Follicle-stimulating hormone (FSH) levels were \<15 IU/mL

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gurgan Clinic: lead

Study Sites (1)

Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, 06640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Granulocyte Colony-Stimulating Factor; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ziya Kalem, MD

  Gurgan Clinic IVF and Women Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: November 1, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

TU (1)