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IRCT20220702055335N1 IRCT 2022-08-09 Vice chancellor for Research,Tabriz Evaluation of the effect of uterine flushing with human chorionic gonadotropin (hCG) on biochemical and clinical pregnancy rate in the IUI cycle of couples with idiopathic infertility Evaluation of the effect of uterine flushing with human chorionic gonadotropin (hCG) on biochemical and clinical pregnancy rate in the IUI cycle of couples with idiopathic infertility 2022-08-06 anticipated 80 Complete https://irct.ir/trial/64556 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are divided into two intervention groups using simple randomization method.The randomization method used in this study is the use of a table of random numbers.Random number table is a set of numbers that is generated without a specific pattern or order and they generated randomly and they are formed in a table.In first the direction of reading the numbers was specified.To read the numbers, random numbers are read from the left side of the table, then even numbers extracted from the table are allocated to intervention group 1 and odd numbers extracted from the table are allocated to intervention group 2, Blinding description: Before prescribing the drug to the patient, the plan is introduced and written consent is received. Study at the patient level, outcome assessor and statistical analyzer of the results will be blinded. 3 Female infertility. Intervention 1: Control group: At the beginning of menstruation and on the third day, an ultrasound will be performed, and from the third day of menstruation, 1 or 2 tablets of letrozole 2.5 mg will be prescribed daily for 5 days. Then, according to the age and state of ovarian reserve, We may inject Cinnal-F ampoule (Cina Gene Pharmaceuticals) 75 units subcutaneously on days 6, 8 and 10. Then on the 10th or 11th day, an ultrasound will be performed and if one or two follicles with a size larger than 18-20 mm and endometrial thickness greater than 7 mm are observed, 10,000 units of hCG will be injected intramuscularly.34-36 hours later the IUI will be performed as usual. In this group, two hours before IUI, 0.5 cc of normal saline will be injected into the uterus as a placebo. Intervention 2: intervention group: At the beginning of menstruation and on the third day, an ultrasound will be performed, and from the third day of menstruation, 1 or 2 tablets of letrozole 2.5 mg will be prescribed daily for 5 days. Then, according to the age and state of ovarian reserve, We may inject Cinnal-F ampoule (Cina Gene Pharmaceuticals) 75 units subcutaneously on days 6, 8 and 10. Then on the 10th or 11th day, an ultrasound will be performed and if one or two follicles with a size larger than 18-20 mm and endometrial thickness greater than 7 mm are observed, 10,000 units of hCG will be injected intramuscularly.34-36 hours later the IUI will be performed as usual. In this group, two hours before IUI,1000 IU hCG will be diluted in 0.5 cc of normal saline and will be injected directly in the uterus cavity. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project, the decision will be made.
public Parvin Hakimi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Parvin Hakimi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Having an informed consent to participate in the study Unexplained infertility diagnosis The health of the uterus structure Normal sperm analysis Women between 20 and 38 years old The presence of ovulation 20 years 38 years Female unsatisfaction for the participation of study Moderate to severe endometriosis hyper prolactinemia Hyperthyroidism Hypothyroidism Ovarian Cysts Kidney and liver failure Blocked fallopian tubes Increased FSH N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Control group: At the beginning of menstruation and on the third day, an ultrasound will be performed, and from the third day of menstruation, 1 or 2 tablets of letrozole 2.5 mg will be prescribed daily for 5 days. Then, according to the age and state of ovarian reserve, We may inject Cinnal-F ampoule (Cina Gene Pharmaceuticals) 75 units subcutaneously on days 6, 8 and 10. Then on the 10th or 11th day, an ultrasound will be performed and if one or two follicles with a size larger than 18-20 mm and endometrial thickness greater than 7 mm are observed, 10,000 units of hCG will be injected intramuscularly.34-36 hours later the IUI will be performed as usual. In this group, two hours before IUI, 0.5 cc of normal saline will be injected into the uterus as a placebo. intervention group: At the beginning of menstruation and on the third day, an ultrasound will be performed, and from the third day of menstruation, 1 or 2 tablets of letrozole 2.5 mg will be prescribed daily for 5 days. Then, according to the age and state of ovarian reserve, We may inject Cinnal-F ampoule (Cina Gene Pharmaceuticals) 75 units subcutaneously on days 6, 8 and 10. Then on the 10th or 11th day, an ultrasound will be performed and if one or two follicles with a size larger than 18-20 mm and endometrial thickness greater than 7 mm are observed, 10,000 units of hCG will be injected intramuscularly.34-36 hours later the IUI will be performed as usual. In this group, two hours before IUI,1000 IU hCG will be diluted in 0.5 cc of normal saline and will be injected directly in the uterus cavity. Clinical pregnancy rate. Timepoint: 28 days after transfer. Method of measurement: vaginal sonography. Chemical pregnancy rate. Timepoint: 14 days after transfer. Method of measurement: BhCG test. Vice chancellor for Research,Tabriz Approved 2022-06-01 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)