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IRCT20211120053119N1 IRCT 2022-01-29 Iran University of Medical Sciences Comparison of effects of an aromatase inhibitor with human gonadotropin in clomiphene-resistant polycystic ovary syndrome Comparison of therapeutic effect of aromatase inhibitor with human gonadotropin in patients with clomiphene-resistant polycystic ovary syndrome 2021-12-06 anticipated 120 Complete https://irct.ir/trial/60131 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Polycystic ovary syndrome, infertility. Intervention 1: Intervention group: in the first step, Patients with induce ovulation were treated with clomiphene (50mg tablet produced by Iran Hormone Company), 100 mg daily from the 5th day of menstruation for 5 days, as well as on the 14th day of the ultrasound cycle. Even by prescribing clomiphene 150 mg for 7 days, patients still have not ovulated. In this study, these patients were considered clomiphene resistant patients and were divided into two equal groups of 60, each of them was placed in one of these two groups. The first group of patients was treated with a combination of clomiphene 100 mg from day 5 to 11 and letrozole 5 mg daily from day 5 to 9 of menstruation. On the 16th day of menstruation, transvaginal ultrasound was performed to check the number and size of follicles. Depending on the patient's condition, if there is at least one follicle above 18 mm, then 1 or 2 ampoules of HCG were prescribed for the final induction of ovulation. Intervention 2: Intervention group: The second group of pateints was treated with a combination of clomiphene 100 mg daily from day 3 to 7 and ampoules of human gonadotropin hormone (ampoule 75 units produced by Karma company) on days 6, 7 and 8 of menstruation. The next doses were adjusted according to the patient's response. On day 18, transvaginal ultrasound was performed to check the size and number of follicles, and patient's condition, if there is at least one follicle above 18 mm, then 1 or 2 ampoules of HCG were prescribed for the final induction of ovulation. Yes - There is a plan to make this available What will be shared: Participants' data such as age, duration of infertility, type of infertility could be shared. When: Access starts 6 months after publishing results To whom: Researchers in academic and scientific institutions Conditions: To find out more about continuing the pregnancy Where to obtain: Visit mdadkhah27@yahoo.com How to obtain: After sending the request to the applicant and reviewing the records, it will be sent via email about a month later. Comments:
public Maryam Dadkhah
Tehran, Hemat Highway next to Milad Tower , 14535
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2220 mdadkhah27@yahoo.com Iran University of Medical Sciences scientific Mahnaz Ashrafy
No 2.Royan Alley, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 8183367898 +98 21 8895 5725 ashrafi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Women with more than one year of infertility and clomiphene resistant polycystic ovary syndrome No significant underlying disease Has one or two open fallopian tubes Spouse normal spermogram 18 years 40 years Female Age out of range Hypo or hyperthyroidism Hyperprolactinemia Anatomical problems of the uterus and fallopian tubes سندرم تخمد سندرم تخمدان پلی کیستیک Treatment - Drugs Treatment - Drugs Intervention group: in the first step, Patients with induce ovulation were treated with clomiphene (50mg tablet produced by Iran Hormone Company), 100 mg daily from the 5th day of menstruation for 5 days, as well as on the 14th day of the ultrasound cycle. Even by prescribing clomiphene 150 mg for 7 days, patients still have not ovulated. In this study, these patients were considered clomiphene resistant patients and were divided into two equal groups of 60, each of them was placed in one of these two groups. The first group of patients was treated with a combination of clomiphene 100 mg from day 5 to 11 and letrozole 5 mg daily from day 5 to 9 of menstruation. On the 16th day of menstruation, transvaginal ultrasound was performed to check the number and size of follicles. Depending on the patient's condition, if there is at least one follicle above 18 mm, then 1 or 2 ampoules of HCG were prescribed for the final induction of ovulation. Intervention group: The second group of pateints was treated with a combination of clomiphene 100 mg daily from day 3 to 7 and ampoules of human gonadotropin hormone (ampoule 75 units produced by Karma company) on days 6, 7 and 8 of menstruation. The next doses were adjusted according to the patient's response. On day 18, transvaginal ultrasound was performed to check the size and number of follicles, and patient's condition, if there is at least one follicle above 18 mm, then 1 or 2 ampoules of HCG were prescribed for the final induction of ovulation. Number of follicles. Timepoint: On the 16th Day of the menstrual cycle. Method of measurement: Vaginal ultrasound machine. Pregnancy rate. Timepoint: one month. Method of measurement: blood test. Endometrial Thickness. Timepoint: On the 16th Day of the menstrual cycle. Method of measurement: Vaginal ultrasound machine. Iran University of Medical Sciences Iran University of Medical Sciences Iran University of Medical Sciences Approved 2019-11-05 Ethics Committee of Iran University of Medical Sciences Tehran, Hemat Highway next to Milad Tower , 14535 Tehran Tehran Iran (Islamic Republic of)