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IRCT20171031037130N2 IRCT 2018-05-07 Iran University of Medical Sciences The effects of Oxytocin on Ovulation and Pregnancy The effects of oxytocin and human chorionic gonadotropin in clomiphene citrate resistant polycystic ovary syndrome patients 2017-10-25 anticipated 126 Complete https://irct.ir/trial/27549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after determining the sample size, Patients were randomly assigned to one of three groups using stratified randomization. Allocation Concealment was performed by sealed envelopes, Blinding description: In this study, a plan was first described for the patient.The patient, the researcher and the physician did not know the group. For each treatment, the code was assigned and placed in an envelop and then put in a box, randomly.The agent who conducted the randomization process, did not engage with other steps. 2 Polycystic ovarian syndrome. Intervention 1: Intervention group 1: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, trans vaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies. Intervention 2: Intervention group 2: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, transvaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 5,000-unit HCG were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies. Intervention 3: Intervention group 3: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, transvaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin and 5,000-unit HCG were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mojgan Javedani Masroor
Shahid Akbar abadi hospital, Molavi intersectino, Molavi Ave,
tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 javedanimasroor.m@iums.ac.ir Iran University of Medical Sciences scientific Mojgan Javedani Masroor
Shahid Akbar abadi hospital, Molavi intersectino, Molavi Ave,
tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 javedanimasroor.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Clomiphen citrate resistant poly cystic ovary syndrome patients 19 - 45 years old At least one ovarian tube is open in HSG Normal Semen analysis of husband No other pelvic pathology 19 years 45 years Female Hypersensitivity to Oxytocin History of Cardio vascular disease Use of anti hypertensive drug blood pressure lower than 60/90 abnormal spermogram hyper prolactinoma anatomical disorder of uterus and tubal factor karyotype disorder E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, trans vaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies Intervention group 2: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, transvaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 5,000-unit HCG were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies Intervention group 3: Letrozole (5 mg) was given since second to the fifth day of the menstrual cycle for 5 days, to grow follicles. Then, transvaginal ultrasonography was performed on thirteenth day of menstrual cycle to measure the dominant follicle size, follicular count and endometrial thickness. In women with a follicle of 18 to 22 mm, to stimulate ovulation, 10-unit of oxytocin and 5,000-unit HCG were injected. Then participants were examined for pregnancy (biochemical or clinical) and abortion and multiple pregnancies Pregnancy percentage. Timepoint: pregnancy test and sonography after induction of ovulation. Method of measurement: serum beta HCG. Iran University of Medical Sciences Approved 2017-10-24 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, tehran Tehran Iran (Islamic Republic of)