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IRCT20230718058835N1 IRCT 2023-08-12 Hamedan University of Medical Sciences Effect of Granulocyte colony stimulating factor (G-CSF) on in-vitro fertilization (IVF) results Effect of subcutaneous Granulocyte colony stimulating factor (G-CSF) versus placebo on in-vitro fertilization (IVF) results in patients with recurrent implantation failure (RIF): A double-blind, randomized, controlled, clinical trial 2023-10-20 anticipated 134 Complete https://irct.ir/trial/71908 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using balanced block randomization, patients will be assigned to one of the two G-CSF and placebo intervention groups. The randomization sequence will be determined by the R program by a person who does not participate in the present study. The patients will receive the boxes sealed with 10-digit codes, which contain the drug or placebo, Blinding description: The participants and the physician will be blinded to allocation and the principal investigator will ensure the blinding of them. 3 female infertility. Intervention 1: Intervention group: Intervention group: Granulocyte Colony Stimulating Factor (G-CSF), 300µg, single dose, subcutaneous, injected one hour before embryo transfer. Intervention 2: Control group: placebo, normal saline, 300µg, subcutaneously, one hour before embryo transfer. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyed Ehsan Mousavi
Mirzakuchakkhan str, No54
Tabriz Iran (Islamic Republic of) 5166753383 +98 41 3332 1925 drehsanmousavii@gmail.com Tabriz University of Medical Sciences scientific Seyed Ehsan Mousavi
Mirzakuchakkhan str, No54
Tabriz Iran (Islamic Republic of) 5166753383 +98 41 3332 1925 drehsanmousavii@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age less than 40 years maximum FSH level of 15 IU/ml repeated IVF failure absence of contraindications to receiving G-CSF (active infection, tuberculosis cycle disease, chronic neutropenia, history of malignancy in the past, current malignancy, renal failure, upper respiratory tract infection, congenital fructose intolerance) absence of any systemic diseases (hypertension, diabetes, antiphospholipid syndrome, lupus, thrombophilia and thyroid diseases) 18 years 40 years Female Insufficient endometrial thickness (minimum 7 mm on the day of HCG injection) hypersensitivity to GCSF diagnosis of Asherman's syndrome diagnosis of polyps and fibroids by hysteroscopy refusal to participate in the study N97.2 Female infertility of uterine origin Treatment - Drugs Placebo Intervention group: Intervention group: Granulocyte Colony Stimulating Factor (G-CSF), 300µg, single dose, subcutaneous, injected one hour before embryo transfer Control group: placebo, normal saline, 300µg, subcutaneously, one hour before embryo transfer Chemical pregnancy rate. Timepoint: two weeks after embryo transfer. Method of measurement: serum level of β-HCG. Clinical pregnancy rate. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Transvaginal ultrasound. Hamedan University of Medical Sciences Approved 2023-05-06 Ethics committee of Hamadan University of Medical Sciences Shahid Fahmideh Blvd, Pazhoohesh sq. Hamadan Hamadan Iran (Islamic Republic of)