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IRCT20080831001141N31 IRCT 2020-12-23 ROYAN Institute The three methods of ovulation induction in patients with polycystic ovarian syndrome The comparison of ovulation induction with Clomiphene Citrate, Letrozole and recombinant FSH in patients with polycystic ovarian syndrome 2018-04-21 anticipated 360 Complete https://irct.ir/trial/53120 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 360 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: The patients in the ovulation induction group with recombinant FSH (r-FSH) will receive 50 IU of r-FSH daily from the third day of the menstrual cycle for 7 days, and a monitoring ultrasound will be performed to determine the ovarian response on the 10th day of the menstrual cycle. If follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 7 days, patients will receive 75 IU of r-FSH per day, and on the 17th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 7 days, patients will receive 100 IU of r-FSH per day, and on the 24th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if no follicles larger than 10 mm are observed, the ovulation induction cycle will be canceled. Intervention 2: Control group: The patients in the ovulation induction group with clomiphene citrate (CC) will receive 50 mg of CC daily from the third day of menstrual cycle for 5 days, and a monitoring ultrasound will be performed to determine the ovarian response on the 10th day of the menstrual cycle. If follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 100 mg of CC per day, and on the 17th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 150 mg of CC per day, and on the 24th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if no follicles larger than 10 mm are observed, the ovulation induction cycle will be canceled. Intervention 3: Control group: The patients in the ovulation induction group with letrozole will receive 2.5 mg of letrozole daily from the third day of the menstrual cycle for 5 days, and a monitoring ultrasound will be performed to determine the ovarian response on the 10th day of the menstrual cycle. If follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 5 mg of letrozole per day, and on the 17th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 7.5 mg of letrozole per day, and on the 24th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if no follicles larger than 10 mm are observed, the ovulation induction cycle will be canceled. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public. Conditions: Scientific use by citing the source. Where to obtain: Dr. Firehouse Ghaffari Email: ghafaryf@yahoo.com How to obtain: Request via e-mail Comments:
public Firouzeh Ghaffari
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 ghafaryf@yahoo.com ROYAN Institute scientific Firouzeh Ghaffari
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 ghafaryf@yahoo.com ROYAN Institute Iran (Islamic Republic of) Infertile women with polycystic ovarian syndrome based on Rotterdam criteria Age 20-37 years Body Mass Index less than 30 Kg/m2 Total Motile Sperm Counts more than one million and normal morphology more than 4% (Husband) 20 years 37 years Female Women with hematologic and autoimmune disorders Couples with chromosomal and genetic abnormalities Women with uterine anomalies Women with uterine and ovaries surgical history Women with endometriosis and adenomyosis Women with hydrosalpinx Women with uterine fibroids Women with recurrent abortion history N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Treatment - Other Intervention group: The patients in the ovulation induction group with recombinant FSH (r-FSH) will receive 50 IU of r-FSH daily from the third day of the menstrual cycle for 7 days, and a monitoring ultrasound will be performed to determine the ovarian response on the 10th day of the menstrual cycle. If follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 7 days, patients will receive 75 IU of r-FSH per day, and on the 17th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 7 days, patients will receive 100 IU of r-FSH per day, and on the 24th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if no follicles larger than 10 mm are observed, the ovulation induction cycle will be canceled. Control group: The patients in the ovulation induction group with clomiphene citrate (CC) will receive 50 mg of CC daily from the third day of menstrual cycle for 5 days, and a monitoring ultrasound will be performed to determine the ovarian response on the 10th day of the menstrual cycle. If follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 100 mg of CC per day, and on the 17th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 150 mg of CC per day, and on the 24th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if no follicles larger than 10 mm are observed, the ovulation induction cycle will be canceled. Control group: The patients in the ovulation induction group with letrozole will receive 2.5 mg of letrozole daily from the third day of the menstrual cycle for 5 days, and a monitoring ultrasound will be performed to determine the ovarian response on the 10th day of the menstrual cycle. If follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 5 mg of letrozole per day, and on the 17th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if follicles larger than 10 mm are observed, the drug will be continued to achieve 18-mm follicles, but if follicles larger than 10 mm are not observed for 5 days, patients will receive 7.5 mg of letrozole per day, and on the 24th day of the menstrual cycle, a monitoring ultrasound will be conducted to determine the ovarian response. At this time, if no follicles larger than 10 mm are observed, the ovulation induction cycle will be canceled. Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational. Timepoint: Only once; at least 20 weeks after embryo transfer. Method of measurement: Clinical information. CinnaGen Company Approved 2018-04-17 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)