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IRCT20180923041093N7 IRCT 2022-07-04 Zahedan University of Medical Sciences Evaluating the effect of dry cupping, and Aslaq capsule, on the infertility Evaluating the effect of dry cupping, and Aslaq capsule, on the incidence of pregnancy in patients with infertility due to polycystic ovary syndrome 2022-07-21 anticipated 120 Complete https://irct.ir/trial/64452 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to four groups is done by permuted block stratified randomization. In this way, eligible patients are first classified according to BMI, consumption or non-consumption of metformin, and regular or irregular menstruation (oligomenorrhea or amenorrhea), respectively. Then, based on the four blocks (consisting of four groups A, B, C and D) that are randomly selected from all possible modes of permutations, they are assigned to the desired group. These blocks are created using R statistical software version 4.0.2. 3 Infertility due to polycystic ovary syndrome. Intervention 1: Intervention group: cupping+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, from the seventh day of the menstrual cycle to the fourteenth day, dry cupping under the abdomen (the area between the upper area of ​​the symphysis pubis bone - above the pubic hairline - and below the navel) will be done using four cups with a diameter of 6 cm. Patients are trained for cupping. In this way, castor oil is applied to the lower abdomen and 4 cups are placed on it, then a vacuum is created by the suction device that is provided to the patients so that the skin protrudes in the glass and becomes slightly red due to the accumulation of blood. The cups are left for 15 to 20 minutes and then gently removed. In the grouping group, if menstruation does not occur on day 35 of the cycle, the beta test is taken from the patient, and if the test is negative, cupping is performed again for 5 days, and if menstruation occurs, the stopping is stopped. If menstruation does not occur with cupping, the patient will be excluded from the study for other treatments. Intervention 2: Intervention group: Aslaq capsule+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, from the first day of cleansing for 21 days, one Asalq capsule in the morning, one capsule at night, then the capsule is cut until menstruation occurs and the next cycle of taking the capsule starts from the first day of cleansing the next cycle. If no menstruation occurs 6 days after discontinuation of the capsule, the beta test is taken from the patient and if the test is negative, the seventh day (seven days after discontinuation of the capsule) the capsule is started again. If menstruation does not occur after two periods of taking the capsule, the patient will be excluded from the study for other treatments. Intervention 3: Intervention group: Aslaq capsule and cupping+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, a combination of Aslaq capsule and cupping is used. The cupping from day 7 to 14 of the menstrual cycle and the capsule are considered for 21 days from the first day of cleansing. In case of no menstruation 6 days after discontinuation of the capsule, the beta test is taken from the patient and if the test is negative, on the seventh day (seven days after discontinuation of the capsule) the capsule is started again and at the same time with the start of the capsule, the cupping is done for 5 days. At this stage, if menstruation occurs, the cupping and the capsule are cut off. If menstruation does not occur after two periods of taking the capsule with the cupping, the patient will be excluded from the study to receive other treatments. Intervention 4: Control group: letrozole - 2.5 mg tablets twice a day, 5 days in a cycle will start from the third day of menstruation. If you do not menstruate after 50 days from the start of the previous cycle, 200 mg of progesterone is prescribed. Yes - There is a plan to make this available What will be shared: After the study, information about the main outcome will be shared When: Access period starts 6 months after the results are published To whom: For academic and scientific researchers only Conditions: Only in line with the analysis and research related to the main title of this study Where to obtain: Email to hashemifa67@gmail.com How to obtain: The data will be provided to the applicant within one month after reviewing and confirming the request. Comments:
public Fatemeh Sadat Hasheminasab
Pharmacology research center, Zahedan university of medical sciences, Hesabi square, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743463 +98 938 238 4249 hashemifa67@gmail.com Zahedan University of Medical Sciences scientific Marzieh Ghasemi
Ali ebne Abi Taleb Hospital, Persian Gulf Highway
Zahedan Iran (Islamic Republic of) 98167 43111 +98 54 3329 5570 drghasemim@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) PCOs based on Rotterdam criteria and diagnosing infertility fellowship Infertility with at least one year of unprotected intercourse Age between 18 and 35 years 18 years 35 years Female Systemic disease requires serious therapeutic interventions premature ovarian failure Single ovarian cyst or breast cyst Endometriosis, Pelvic Adhesions, Tube Obstruction, Tube Abnormalities, and Hyperprolactinemia Infertility due to male factor E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: cupping+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, from the seventh day of the menstrual cycle to the fourteenth day, dry cupping under the abdomen (the area between the upper area of ​​the symphysis pubis bone - above the pubic hairline - and below the navel) will be done using four cups with a diameter of 6 cm. Patients are trained for cupping. In this way, castor oil is applied to the lower abdomen and 4 cups are placed on it, then a vacuum is created by the suction device that is provided to the patients so that the skin protrudes in the glass and becomes slightly red due to the accumulation of blood. The cups are left for 15 to 20 minutes and then gently removed. In the grouping group, if menstruation does not occur on day 35 of the cycle, the beta test is taken from the patient, and if the test is negative, cupping is performed again for 5 days, and if menstruation occurs, the stopping is stopped. If menstruation does not occur with cupping, the patient will be excluded from the study for other treatments. Intervention group: Aslaq capsule+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, from the first day of cleansing for 21 days, one Asalq capsule in the morning, one capsule at night, then the capsule is cut until menstruation occurs and the next cycle of taking the capsule starts from the first day of cleansing the next cycle. If no menstruation occurs 6 days after discontinuation of the capsule, the beta test is taken from the patient and if the test is negative, the seventh day (seven days after discontinuation of the capsule) the capsule is started again. If menstruation does not occur after two periods of taking the capsule, the patient will be excluded from the study for other treatments. Intervention group: Aslaq capsule and cupping+ Letrozole- 2.5 mg letrozole tablets twice a day, on days 3 to 7 of menstruation. Moreover, a combination of Aslaq capsule and cupping is used. The cupping from day 7 to 14 of the menstrual cycle and the capsule are considered for 21 days from the first day of cleansing. In case of no menstruation 6 days after discontinuation of the capsule, the beta test is taken from the patient and if the test is negative, on the seventh day (seven days after discontinuation of the capsule) the capsule is started again and at the same time with the start of the capsule, the cupping is done for 5 days. At this stage, if menstruation occurs, the cupping and the capsule are cut off. If menstruation does not occur after two periods of taking the capsule with the cupping, the patient will be excluded from the study to receive other treatments. Control group: letrozole - 2.5 mg tablets twice a day, 5 days in a cycle will start from the third day of menstruation. If you do not menstruate after 50 days from the start of the previous cycle, 200 mg of progesterone is prescribed. Time of pregnancy occurrence. Timepoint: After the intervention. Method of measurement: sonography or BHCG. Menstrual pain. Timepoint: Monthly. Method of measurement: Visual analogue scale. The length of the menstrual cycle. Timepoint: Monthly. Method of measurement: Time interval from the first day of menstrual bleeding to the last day of menstrual bleeding in a cycle. Based on the person's response to the questionnaire. Ovulation rate. Timepoint: Monthly. Method of measurement: Ultrasonography. Endometrial thickness. Timepoint: Monthly - Day 13 of the menstrual cycle. Method of measurement: Ultrasonography. Follicle growth. Timepoint: Monthly - Day 13 of the menstrual cycle. Method of measurement: Ultrasonography. Sexual function. Timepoint: At the beginning of the intervention, three and six months after the start of the intervention. Method of measurement: Female sexual function index. Zahedan University of Medical Sciences Approved 2022-04-17 Research Ethics Committees of Zahedan University Of Medical Sciences Dr. Hesabi Square, Persian Gulf Boulevard - Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)