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IRCT20221112056477N1 IRCT 2022-12-04 Sanandaj University of Medical Sciences The effect of low-dose aspirin on the success rate of ovulation induction in women with polycystic ovary syndrome Investigating the effect of low-dose aspirin on the success rate of ovulation induction in women with polycystic ovary syndrome 2023-01-21 anticipated 120 Complete https://irct.ir/trial/66832 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering that there are 4 groups under investigation and each group receives one of A, B, C, or D treatments 4 random blocks are formed as follows: ABCD, ACBD, ADCB, ADBC, ACDB, ABDC, BACD, BCAD, BDCA, BDAC, BCDA, BADC, CBAD, CBDA, CABD, CADB, CDAB, CDBA, DBCA, DBAC, DCBA, DCAB, DABC, DACB, Each time and for every 4 new patients who will enter the study, one of the above blocks will be randomly selected, and based on the order in the selected block, they will receive one of the A, B, C, or D treatments, Blinding description: This is a double-blind study. The patients and the main researcher do not know the type of treatment received by the groups. The statistical analysis will be done by another researcher who is unaware of the type of treatment received by the different groups. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: The first group: recipients of clomiphene citrate with a dose of 50 to 150 mg from the day of the 3rd cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study. Intervention 2: Intervention group: The second group: receiving letrozole at a dose of 5 to 7.5 mg from day 3 of the cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study. Intervention 3: Intervention group: The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study. Intervention 4: The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study. Yes - There is a plan to make this available What will be shared: The research data will be provided to the requestors without mentioning the personal characteristics of the research participants. When: After the end of the research and confirmation of the obtained results and obtaining permission from the university, the information will be provided. To whom: Government and private research institutes and people who are interested in research in the studied field. Conditions: In order to continue the research and complete the obtained protocol. Where to obtain: Research assistant of the faculty How to obtain: The request will be submitted to the research vice-chancellor of the faculty. If approved, it will be sent to the supervisor, and if approved, the information will be provided to the applicant. Comments:
public Liravi Hosna
Pasdaran
Sanandaj Iran (Islamic Republic of) 6619667763 +98 87 3328 5912 liravihosna@gmail.com Sanandaj University of Medical Sciences scientific Liravi Hosna
Pasdaran
Sanandaj Iran (Islamic Republic of) 7184877699 +98 87 3328 5911 liravihosna@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 20 to 35 years Body mass index less than 30 kg/m2 Suffering from the polycystic ovary, according to Rotterdam criteria 20 years 35 years Female Other causes of infertility Male factor Abnormal thyroid function tests Abnormal prolactin levels Diabetes Anatomical disorder in hysterosalpingography or laparoscopy Endometriosis E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first group: recipients of clomiphene citrate with a dose of 50 to 150 mg from the day of the 3rd cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study. Intervention group: The second group: receiving letrozole at a dose of 5 to 7.5 mg from day 3 of the cycle to 3 months after ovulation + placebo daily until pregnancy or the end of the study. Intervention group: The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study The third group: recipients of clomiphene citrate at a dose of 50 to 150 mg from day 3 of the cycle until 3 months after ovulation + oral aspirin at a dose of 80 mg daily from the third day of the previous menstrual cycle until pregnancy or termination. study Ovulation induction. Timepoint: On the 14th day of the menstrual cycle and Every day for the next two weeks. Method of measurement: Serum levels of human chorionic gonadotropin. Pregnancy. Timepoint: Day 14 of the cycle. Method of measurement: Transvaginal ultrasound. Do Quitos. Timepoint: Three times a week. Method of measurement: Transvaginal ultrasound. Measurement of human chorionic gonadotropin-beta serum level. Timepoint: two weeks later. Method of measurement: Serum test. Gestational sac. Timepoint: Six weeks later. Method of measurement: Transvaginal ultrasound. Sanandaj University of Medical Sciences Approved 2022-01-02 Ethics committee of Kurdistan University of Medical Sciences Besat Hospital, Department of Obstetrics and Gynecology, Sanandaj, Kurdistan, Iran sanandaj Kurdistan Iran (Islamic Republic of)