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IRCT20160703028756N6 IRCT 2021-10-13 Esfahan University of Medical Sciences Evaluation of intrauterine insemination (IUI) catheter (Mandrel contain) in infertile couples Evaluation of effectiveness and side effects of intrauterine insemination catheter with mandrel, a product of Slamtyar Hakim engineering company, in infertile couples 2020-06-21 anticipated 60 Complete https://irct.ir/trial/50302 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning samples to groups is in the form of two-treatment permutation block design with quadruple blocks. Thus, the letter A is considered for the masstec catheter group with mandrel and the letter B for the catheter group without mandrel. Then we write all the permutation compounds of the letters A, A, B, B, which are 6 different compounds, then we choose a number from the digits 1 to 6. For example, if the number 2 is selected, it means that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group. This operation continues until the sample size reaches the quorum. N/A Female infertility. Intervention 1: Control group:In the control group, including 30 patients, the catheter without mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm. Intervention 2: Intervention group: In the intervention group, including 30 patients, the catheter with mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm. 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 No more information
public Fatemeh Maghool
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
Isfahan Iran (Islamic Republic of) 8169333463 +98 31 9501 6799 fmaghool@gmail.com Poursina Hakim Digestive Diseases Research Center scientific Fatemeh Maghool
No. 12, Yas Block 8, Keshvari Complex, Third Abshar Ave.
Isfahan Iran (Islamic Republic of) 8169333463 +98 95016799 fmaghool@gmail.com Poursina Hakim Digestive Diseases Research Center Iran (Islamic Republic of) Having 2 to 3 follicles of suitable size, open tubes acceptable sperm test for intrauterine insemination no limit 42 years Female Age over 42 years bilateral tubular obstruction couples with sperm concentration less than ten million spermatozoa per millilitre N97 Female infertility Treatment - Devices Treatment - Devices Control group:In the control group, including 30 patients, the catheter without mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm. Intervention group: In the intervention group, including 30 patients, the catheter with mandrel, produced by Salamatyar Hakim engineering Company, will be used for intrauterine insemination of sperm. Problem with catheter insertion. Timepoint: At the time of intrauterine insemination. Method of measurement: Questionnaire. Need to Tenaculum. Timepoint: At the time of intrauterine insemination. Method of measurement: Questionnaire. Need for cervical dilatation. Timepoint: At the time of intrauterine insemination. Method of measurement: Questionnaire. Chemical pregnancy rate. Timepoint: 2 weeks after intrauterine insemination. Method of measurement: Human chorionic gonadotropin Test. Clinical pregnancy rate. Timepoint: 5 weeks after intrauterine insemination. Method of measurement: Sonography. Salamat Yar Hakim Engineering Co Esfahan University of Medical Sciences Salamat Yar Hakim Engineering Co Approved 2021-05-29 Ethics Committee of Isfahan University of Medical Sciences Deputy of research and technology, Isfahan University Of Medical Sciences, Hezarjerib St. Isfahan Isfehan Iran (Islamic Republic of)