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IRCT20200122046221N2 IRCT 2020-08-21 Jahrom University of Medical Sciences Induction of ovulation in women with ovarian laziness Ovulation induction with clomiphene citrate and letrozole vesus letrozole and cabergoline in fertility rate and its complications in infertile polycystic ovary syndrome women referred to gynecologic clinic 2020-08-05 anticipated 60 Complete https://irct.ir/trial/49697 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, a simple randomization method will be used, which based on the list of samples and their numbering using a table of random numbers (using Random Allocation Software 1.0) that people are divided into two groups.The first group will induce ovulation with clomiphene citrate and letrozole and the second group will induce ovulation with letrozole and cabergoline. -Randomization method and description of each method: Simple randomization -Randomization unit: individual -Randomization layers: In this study, there is no simple layer due to the type of random allocation. -Randomization tool: Random number table (using Random Allocation Software 1.0). -How to make a random sequence: According to the use of software and the definition of two groups and the number of sample sizes required in each, the group for the software numbers are randomly assigned in two groups, it is obvious that each number represents one of the sample. -Explanation about allocation concealment: Concealment was done centrally by the Statistics Counseling Center of Jahrom University of Medical Sciences and by one of the statistical consultants so that the researcher does not interfere in assigning samples to groups, Blinding description: While obtaining written consent from patients to participate in the study They only knew that they were studying to find the best way to induce ovulation, but they did not know which group of drugs was included in the drug coding,in order to observe ethics in the research, the structure of the study was explained to them and after their agreement, the samples were included in the study (Single blind).the ampoules and tablets were presented to the researchers in similar syringes and covers respectively (with special codes ) so that it could not be identified for the assistant researchers (the nurse of Jahrom Women's Clinic). Accordingly, the assistant researchers participated in prescribing the drug to patients, although they knew what the drug's content was in each package, were unaware of the research hypotheses.It should be noted that the participants in each group were unaware of the drug regime of the opposite group.(Double blind). Because the researcher(the gynecologist and professor of Jahrom University of Medical Sciences) did not know about the coding system but the assistant researchers knew about this system. Therefore, until the end of the analysis and before the generalization of the calculations, the researcher did not know which group the collected data belonged to.Obviously, the assistant researchers wrote down the data belonging to the groups somewhere and gave it to the researcher after analyzing the data (Triple blind). 3 Polycystic Ovary Syndrome(PCO). Intervention 1: First Intervention group: From the third to the seventh day of menstruation, they take two clomiphene 50 mg tablets (100 mg in total) daily, and then from the eighth to the eleventh day of menstruation, they take two 2.5 mg letrozole tablets (5 mg in total). On the 8th and 12th days of the Menstrual cycle Transvaginal ultrasound will be performed to check the number of follicles, the size of the follicles that have grown, and the thickness of the endometrium.If the size of the follicle is more than 18 mm, HCG ampoule is injected from 5000 to 10,000 units depending on the number and size of the follicle.(CLOMIPHENE CITRATE TABLET ORAL 50 mg with OVUMID brand from Iran Hormone Company) (LETROZOLE TABLET ORAL 2.5 mg with LETROFEM brand from Iran Hormone Company) (CHORIONIC GONADOTROPHIN (HUMAN) INJECTION, POWDER, FOR SOLUTION PARENTERAL 5000 [iU] with IVF-C brand from Arman Pharmed Daru company). Intervention 2: Second Intervention group: From the third to the eleventh day, they take two 2.5 mg letrozole tablets daily (5 mg in total) and then from the eighth day, they take two 0.5 mg cabergoline tablets daily until the eleventh day.On the 8th and 12th days of the Menstrual cycle Transvaginal ultrasound will be performed to check the number of follicles, the size of the follicles that have grown, and the thickness of the endometrium.If the size of the follicle is more than 18 mm, HCG ampoule is injected from 5000 to 10,000 units depending on the number and size of the follicle.(LETROZOLE TABLET ORAL 2.5 mg with LETROFEM brand from Iran Hormone Company) (CABERGOLINE TABLET ORAL 0.5 mg with CABERLIN brand from Iran Hormone Company) (CHORIONIC GONADOTROPHIN (HUMAN) INJECTION, POWDER, FOR SOLUTION PARENTERAL 5000 [iU] with IVF-C brand from Arman Pharmed Daru company). Yes - There is a plan to make this available What will be shared: Data would be presented according to the jahrom university of medical sciences protocols When: According to the jahrom university of medical sciences protocols To whom: According to the jahrom university of medical sciences protocols Conditions: According to the jahrom university of medical sciences protocols Where to obtain: Jahrom university of medical sciences How to obtain: According to the jahrom university of medical sciences protocols Comments:
public Athar Rasekh Jahromi
Jahrom-Ostad Motahari Street-After School of Nursing-Jahrom University of Medical Sciences-Pardis site
Jahrom Iran (Islamic Republic of) ۷۴۱۴۸-۴۶۱۹۹ +98 71 5433 1521 Drrasekh@yahoo.com Jahrom University of Medical Sciences scientific Athar Rasekh Jahromi
Jahrom-Ostad Motahari Street-After School of Nursing-Jahrom University of Medical Sciences-Pardis site
Jahrom Iran (Islamic Republic of) ۷۴۱۴۸-۴۶۱۹۹ +98 71 5433 1521 Drrasekh@yahoo.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Infertile women with polycystic ovary syndrome who have not had a history of pregnancy without contraception after 12 months Women with no ovulation Normal hysterosalpingography with open fallopian tubes Diagnosis of infertility by non-ovulation, which is diagnosed according to standard criteria Written conscious desire and satisfaction Infertility at the age of 15-45 years 15 years 45 years Female Uterine and adnexal pathology such as leiomyoma, endometriosis, etc. Hyperprolactinemia/Hyperthyroidism or hypothyroidism Liver or kidney dysfunction Diabetes mellitus or random blood sugar above 140 mg / dL Previous genital surgery Appendicitis, peritonitis, genital tuberculosis in history or having abnormal pelvic anatomy FSH above 9 in the early stage of the follicular phase E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs First Intervention group: From the third to the seventh day of menstruation, they take two clomiphene 50 mg tablets (100 mg in total) daily, and then from the eighth to the eleventh day of menstruation, they take two 2.5 mg letrozole tablets (5 mg in total). On the 8th and 12th days of the Menstrual cycle Transvaginal ultrasound will be performed to check the number of follicles, the size of the follicles that have grown, and the thickness of the endometrium.If the size of the follicle is more than 18 mm, HCG ampoule is injected from 5000 to 10,000 units depending on the number and size of the follicle.(CLOMIPHENE CITRATE TABLET ORAL 50 mg with OVUMID brand from Iran Hormone Company) (LETROZOLE TABLET ORAL 2.5 mg with LETROFEM brand from Iran Hormone Company) (CHORIONIC GONADOTROPHIN (HUMAN) INJECTION, POWDER, FOR SOLUTION PARENTERAL 5000 [iU] with IVF-C brand from Arman Pharmed Daru company) Second Intervention group: From the third to the eleventh day, they take two 2.5 mg letrozole tablets daily (5 mg in total) and then from the eighth day, they take two 0.5 mg cabergoline tablets daily until the eleventh day.On the 8th and 12th days of the Menstrual cycle Transvaginal ultrasound will be performed to check the number of follicles, the size of the follicles that have grown, and the thickness of the endometrium.If the size of the follicle is more than 18 mm, HCG ampoule is injected from 5000 to 10,000 units depending on the number and size of the follicle.(LETROZOLE TABLET ORAL 2.5 mg with LETROFEM brand from Iran Hormone Company) (CABERGOLINE TABLET ORAL 0.5 mg with CABERLIN brand from Iran Hormone Company) (CHORIONIC GONADOTROPHIN (HUMAN) INJECTION, POWDER, FOR SOLUTION PARENTERAL 5000 [iU] with IVF-C brand from Arman Pharmed Daru company) The size of the grown follicles. Timepoint: Days 8 and 12 of the menstrual cycle. Method of measurement: Transvaginal ultrasound. Number of grown follicles. Timepoint: Days 8 and 12 of the menstrual cycle. Method of measurement: Transvaginal ultrasound. Endometrial thickness. Timepoint: Days 8 and 12 of the menstrual cycle. Method of measurement: Transvaginal ultrasound. Jahrom University of Medical Sciences Jahrom University of Medical Sciences Jahrom University of Medical Sciences Approved 2020-07-12 Ethics Committee of Jahrom University of Medical Sciences Jahrom-Ostad Motahari Street-After School of Nursing-Jahrom University of Medical Sciences-Pardis site. Jahrom Fars Iran (Islamic Republic of)