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IRCT20160815029374N6 IRCT 2019-05-24 Mazandaran University of Medical Sciences Effects of letrozole in combination with clomiphene on infertility Comparison of the effects of letrozole with letrozole in combination with clomiphene on ovulation and pregnancy rate in infertile patients with polycystic ovarian syndrom under Ovulation induction 2019-04-04 anticipated 194 Complete https://irct.ir/trial/35488 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first phase of sampling, after applying the criteria for entry and exclude, samples are selected in an accessible manner. Individuals with the criteria for entering, informed consent are obtained. Then, in the second phase, the samples will be assigned to two groups by blocking method. Create blocks and generate random numbers with Random allocation soft ware. The thirty-two blocks of size six will be produced and arranged by the project manager, Blinding description: The individuals implementing the intervention and evaluating the outcome will not be aware of the allocation of participants. 3 Disease of genitourinary tract. Intervention 1: Intervention group 1: Letrozole (2.5 mg tablet, Iranian hormones Company) is given twice daily from the third to seventh day of the menstrual cycle. Intervention 2: Intervention group 2: Clomiphene 2 tablets daily (50 mg tablets, Iran hormones) and Letrozole (2.5 mg tablets, Iran Hormones Company) oral،twice daily from the third to seventh day of the menstrual cycle. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Marzieh Zamanian
Ground floor, IVF ward, NO 233, Imam Khomeini Hospital, Amirmazandarani Ave
sari Iran (Islamic Republic of) 33456578 +98 11 3336 5724 m.zamanian@mazums.ac.ir Mazandaran University of Medical Sciences scientific marzieh zamanin
Ground floor, IVF ward, NO 233, Imam Khomeini Hospital, Amirmazandarani Ave
sari Iran (Islamic Republic of) 33456578 +98 33365724 m.zamanian@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Female aged 35 or lower Mild male factor infertility Poly cyctic ovarian syndrome 20 years 35 years Female Reluctance to participate in study Body mass index above 27 Endocrine disorder including Hypothyroidism, hyperprolactinemia Diminished ovarian reserve History of pelvic surgery History of ovarian hyperstimulation syndrome Severe male factor infertility Abnormal hysterosalpingography Female inf Female infertility Treatment - Drugs Treatment - Drugs Intervention group 1: Letrozole (2.5 mg tablet, Iranian hormones Company) is given twice daily from the third to seventh day of the menstrual cycle. Intervention group 2: Clomiphene 2 tablets daily (50 mg tablets, Iran hormones) and Letrozole (2.5 mg tablets, Iran Hormones Company) oral،twice daily from the third to seventh day of the menstrual cycle. Clinical pregnancy rate. Timepoint: Three weeks after positive B-HCG. Method of measurement: ultrasonography. Ovulation rate. Timepoint: Forty-eight hours after HCG injection. Method of measurement: ultrasonography. Mazandaran University of Medical Sciences Approved 2019-03-06 Ethics committee of Mazandaran University of Medical Sciences No. 240,Ground Floor, Joibar Ave., Mazandaran University of Medical Sciences., Sari Sari Mazandaran Iran (Islamic Republic of)