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IRCT20151123025202N11 IRCT 2020-06-30 Hamedan University of Medical Sciences In Vitro Fertilization Evaluation of the Effect of Melatonin on In Vitro Fertilization (IVF) in Women with Poly Cystic Ovarian 2020-07-22 anticipated 320 Complete https://irct.ir/trial/48953 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We made 16 cards and write letters MT on 8 for Metformin group and on the other 8 letters ML for Melatonin group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter MT or ML patients will be assigned to Metformin or melatonin group and the opened envelope is left out. After completing all the envelopes, we return them to the box and repeat this process up to 20 times to reach the specified sample size, Blinding description: Melatonin and metformin capsules will be available in the same shapes as A and B labels. 3 Infertility due to polycystic ovary syndrome. Intervention 1: Intervention group: After initial evaluations by a physician and doing uterine and ovarian ultrasounds on days 1 to 3 of the menstrual cycle will be treated with metformin plus melatonin and folic acid from the fifth day of menstruation until ovulation., At tenth day of menstruation, hCG will be prescribed and another ultrasound will be performed to check endometrium thickness , AFC and follicle size. If necessary, 75 HMG units intramuscular injected. Vaginal ultrasound is performed until a suitable follicle size (greater than or equal to 18 mm) observed. After 36-40 hours, patients undergo IUI. Intervention 2: Control group: After initial evaluations by a physician and doing uterine and ovarian ultrasounds on days 1 to 3 of the menstrual cycle will be treated with folic acid and metformin without melatonin from the fifth day of menstruation until ovulation., At tenth day of menstruation, hCG will be prescribed and another ultrasound will be performed to check endometrium thickness , AFC and follicle size. If necessary, 75 HMG units intramuscular injected. Vaginal ultrasound is performed until a suitable follicle size (greater than or equal to 18 mm) observed. After 36-40 hours, patients undergo IUI. 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 Abbas Moradi
Shahid Vahmideh Ave
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Abbas Moradi
Shahid Fahmideh Ave
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3838 0557 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age <40 years No Symptoms of hyperendrogenism Abnormal menstrual cycles Use IVF assisted reproductive techniques for the first or second time No fertility problems in the patient's spouse Natural uterine cavity according to hysterosalpingography result no limit 40 years Female Presence of underlying disease Drug Interactions Use of hormonal drugs in the last three months Inadequate ovarian response defects N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Intervention group: After initial evaluations by a physician and doing uterine and ovarian ultrasounds on days 1 to 3 of the menstrual cycle will be treated with metformin plus melatonin and folic acid from the fifth day of menstruation until ovulation., At tenth day of menstruation, hCG will be prescribed and another ultrasound will be performed to check endometrium thickness , AFC and follicle size. If necessary, 75 HMG units intramuscular injected. Vaginal ultrasound is performed until a suitable follicle size (greater than or equal to 18 mm) observed. After 36-40 hours, patients undergo IUI. Control group: After initial evaluations by a physician and doing uterine and ovarian ultrasounds on days 1 to 3 of the menstrual cycle will be treated with folic acid and metformin without melatonin from the fifth day of menstruation until ovulation., At tenth day of menstruation, hCG will be prescribed and another ultrasound will be performed to check endometrium thickness , AFC and follicle size. If necessary, 75 HMG units intramuscular injected. Vaginal ultrasound is performed until a suitable follicle size (greater than or equal to 18 mm) observed. After 36-40 hours, patients undergo IUI. Chemical pregnancy. Timepoint: 14 day after intra uterine insemination. Method of measurement: B_HCG. Clinical Pregnancy. Timepoint: 6 and 20 weeks after B-HCG positive. Method of measurement: sonography. Hamedan University of Medical Sciences Approved 2020-06-16 Ethics committee of Hamadan University of Medical Science ُShahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)