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IRCT20190507043502N1 IRCT 2019-05-26 Sanandaj University of Medical Sciences Comparison of clomiphene citrate stair-step protocol with standard protocol on treatment of infertility Comparison of clomiphene citrate stair-step protocol with standard protocol on ovulation induction and treatment of infertility in women with polycystic ovarian syndrome 2019-05-22 anticipated 60 Complete https://irct.ir/trial/39430 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher goes to the clinic daily. Each patient who has inclusion criteria to enroll in the study is considered as a sample. Samples are divided into 2 groups A and B by computer random selection.Patients are randomly divided into two intervention and control groups based on randomized block method, for example: ABAB / AABB / BBAA, Blinding description: Women in the study are unaware of how they are grouped. 3 Ovulation induction. Intervention 1: Intervention group: From the third day of menstruation, 50 mg of clomiphene citrate is administered daily to the patients for 5 days and on 14th day of menstruation ultrasound is performed.If the size of the follicles was less than 12 mm, then 100 mg of clomiphene citrate is administered daily for another 5 days and on the 20th day of the menstruation ultrasound is performed. If the size of the follicles was less than 12 mm then for another 5 days, 150 mg of clomiphene citrate is administered daily to the patients and on the 25th day of menstruation ultrasound is performed. Intervention 2: Intervention group: From the third day of menstruation, 50 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation.If ovulation is not induced, in the next month from the third day of menstruation, 100 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation, and if ovulation is not induced, in the next month (the third month) from the third day of menstruation, 150 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation. Yes - There is a plan to make this available What will be shared: Part of the data on the primary outcome is for sharing. When: One year after the publication the data will be available. To whom: Researchers working in academic and scientific institutions Conditions: Meta-analysis is allowed on the data of this study. Where to obtain: Dr. Solmaz Ghasemi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: solmaz.ghasemi@muk.ac.ir How to obtain: After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email. Comments:
public Solmaz Ghasemi
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3366 4673 solmaz.ghasemi@muk.ac.ir Sanandaj University of Medical Sciences scientific Sholeh Shahgheibi
Keshavarz St, Besat Hospital, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3328 5910 shahgheibi@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Infertility due to polycystic ovarian syndrome resistant to treatment willingness to participate in the study 18 years 40 years Female Age over forty years N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Intervention group: From the third day of menstruation, 50 mg of clomiphene citrate is administered daily to the patients for 5 days and on 14th day of menstruation ultrasound is performed.If the size of the follicles was less than 12 mm, then 100 mg of clomiphene citrate is administered daily for another 5 days and on the 20th day of the menstruation ultrasound is performed. If the size of the follicles was less than 12 mm then for another 5 days, 150 mg of clomiphene citrate is administered daily to the patients and on the 25th day of menstruation ultrasound is performed. Intervention group: From the third day of menstruation, 50 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation.If ovulation is not induced, in the next month from the third day of menstruation, 100 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation, and if ovulation is not induced, in the next month (the third month) from the third day of menstruation, 150 mg of clomiphene is administered daily for 5 days, and ultrasound is performed on the 14th day of menstruation. The size of follicles. Timepoint: The days 14, 20, 25 of the cycle. Method of measurement: Transvaginal ultrasonography. Sanandaj University of Medical Sciences Approved 2018-12-25 Ethics committee of Kurdistan University of Medical Sciences Pasdaran St., Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)