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IRCT20150407021653N20 IRCT 2023-12-14 Jahrom University of Medical Sciences Comparison of therapeutic results of letrozole, tamoxifen, estradiol and vitamin E regimen with letrozole, tamoxifen and estradiol regimen in stimulating ovulation in infertile women with polycystic ovary syndrome: a double-blind randomized clinical trial study Comparison of therapeutic results of letrozole, tamoxifen, estradiol and vitamin E regimen with letrozole, tamoxifen and estradiol regimen in stimulating ovulation in infertile women with polycystic ovary syndrome: a double-blind randomized clinical trial study 2024-01-30 anticipated 90 Complete https://irct.ir/trial/71936 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, computer block randomization (block size of 12) will be performed An independent epidemiologist not involved in the study will use a computerized block randomization program to generate allocation codes. The randomization sequences will be placed in sealed, light-resistant envelopes.The research assistant will open the sealed, numbered and opaque envelopes containing the allocation codes. After signing the informed consent form, the eligible participants will be divided into two equal groups of Letrozole, Tamoxifen, Estradiol, Vitamin E and Letrozole, Tamoxifen. , estradiol, Blinding description: In this study, blinding is done bilaterally. None of the participants and outcome assessors know which study group someone is in. It should be mentioned that at the beginning of the study, the general introduction of the study groups will be done for the participants and after getting their consent, random allocation will be done and the participants will be randomly assigned to two treatment groups A and B. Also, the controller, who examines the patients from the beginning to the end of the study in the obstetrics and gynecology clinic, is not aware of which group the patient is in. 2-3 Polycystic ovary syndrome. Intervention 1: Intervention group: People participating in the study are randomly divided into two groups A and B with equal sample size.For group A, from the third to the seventh day of the menstrual cycle, daily letrozole at a dose of 5 mg (two tablets of letrozole 2.5 mg), tamoxifen at a dose of 20 mg (10 mg twice a day), estradiol and vitamin E at a dose of 100 mg is prescribed daily for 25 days. Intervention 2: Control group: People participating in the study are randomly divided into two groups A and B with equal sample size.For group B (control), from the third to the seventh day of the menstrual cycle, daily letrozole at a dose of 5 mg (two tablets of letrozole 2.5 mg), tamoxifen at a dose of 20 mg (10 mg twice a day), estradiol for 25 The day is prescribed. 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 There is no further information.
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Jahrom Iran (Islamic Republic of) 7415713945 +98 71 5434 2006 a.rasekh@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Female gender Infertile who have not had a history of pregnancy after 12 months of unprotected intercourse Suffering from polycystic ovary syndrome At least 40 years old 40 years no limit Female Non-consent to participate in the study drug sensitivity to letrozole or tamoxifen or estradiol or vitamin E the existence of any other pathology that has led to infertility in the patient or his wife liver or kidney dysfunction diabetes mellitus type one or two Thyroid disordes congenital adrenal hyperplasia abnormal hysterosalpingography Treatment - Drugs Treatment - Drugs Intervention group: People participating in the study are randomly divided into two groups A and B with equal sample size.For group A, from the third to the seventh day of the menstrual cycle, daily letrozole at a dose of 5 mg (two tablets of letrozole 2.5 mg), tamoxifen at a dose of 20 mg (10 mg twice a day), estradiol and vitamin E at a dose of 100 mg is prescribed daily for 25 days Control group: People participating in the study are randomly divided into two groups A and B with equal sample size.For group B (control), from the third to the seventh day of the menstrual cycle, daily letrozole at a dose of 5 mg (two tablets of letrozole 2.5 mg), tamoxifen at a dose of 20 mg (10 mg twice a day), estradiol for 25 The day is prescribed Pregnancy. Timepoint: One day after the fall in menstruation. Method of measurement: ß-HCG titer test. Follicle size, follicle number and follicle thickness. Timepoint: Days 3, 7 and 12 of the cycle. Method of measurement: sonography. Multiple births. Timepoint: Week 6 of pregnancy. Method of measurement: sonography. Drug side effects. Timepoint: The total time of the intervention. Method of measurement: Examination by the doctor and self-reported by the patient based on previous training. Jahrom University of Medical Sciences Approved 2023-02-19 research ethic committee of Jahrom university of medical science Motahari Boulevard, Shahidan Firouzi Street, Jahrom University of Medical Sciences jahrom Fars Iran (Islamic Republic of)