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IRCT20201219049758N1 IRCT 2021-01-02 Tehran University of Medical Sciences Comparison effect of Metformin and combination of acid folic and myo-inositol" in poly cystic ovary syndrome" Comparison of the effect of metformin and the combination of acid folic and myo-inositol in infertility patients with poly cystic ovary syndrom (PCOS) who undergoing IVF for the test time. 2018-08-23 anticipated 140 Complete https://irct.ir/trial/53363 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule:First, 70 letters A and 70 letters B were written on special papers that were not marked inside. Then all of them were placed in a bag and for each patient, after obtaining informed consent, a paper was removed randomly and without replacement, and based on the letter written on it, the desired intervention was performed for the patient. In addition, interventions A or B were determined by a lot, Blinding description: This study is performed as double-blind, the researcher and the analyzer do not know the type of treatment. The drug is used by the infertility resident physician for the patient after random selection. 3 Infertility, Polycystic ovary syndrome. Intervention 1: Intervention group: Received combination of 2000 mg and 200 micro gr Folic acid twice a day. Intervention 2: Control group: Received 500 mg three time a day. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participant When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr.Rezaee and my analysis done with must be done with her opinion . Where to obtain: Dr. Zahra rezee How to obtain: Any reqeust must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Rezee Comments:
public Fereshteh rastegar
No.10, Yas steet., Norhtern Vafa azar Aven, West Ferdows Blvn,
Tehran Iran (Islamic Republic of) 1481863373 +98 21 4403 4589 rastegar.freshteh@gmail.com Tehran University of Medical Sciences scientific Zahra rezee
Yas Hospital, Next to the sarv street, Norhtern Nejatollahi Karimkhan
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 zhrrezee@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) First IVF No histoty of ovarian manipulation Lack of male infertility factor Patency of fallupian tubes No history of smoking 18 years 40 years Female History of IVF histoty of ovarian manipulation male infertility factor No patency of fallupian tubes history of smoking Treatment - Drugs Treatment - Drugs Intervention group: Received combination of 2000 mg and 200 micro gr Folic acid twice a day Control group: Received 500 mg three time a day Improving fertility in patients with polycystic ovary syndrome. Timepoint: Before starting the drug from three months before the start of the IVF cycle until the puncture and then before the puncture then comparison of two drug in fertilization rate. Method of measurement: HCG, Ultrasound. Body Mass Index, Fertilization rate, Abortion rate, EP rate, OHSS rate, Ovum count, Ovum quality, Embryo count, , Embryo quality, Follicle count,Follicle size. Timepoint: Patients took the drug three months before the start of the IVF cycle until the puncture, Body Mass Index was measured before and after the drug was completed. Method of measurement: Body Mass Index: weight(kg) on height(cm2), Fertility: HCG and ultrasound, Abortion: HCG and ultrasound, EP: HCG and ultrasound, OHSS: ultrasound, Follicle size: ultrasound, Follicle count: ultrasound, ovum count: microscopic and embryologist, ovum quality: microscopic and embryologist, Embryo count: microscopic and embryologist, Embryo quality: microscopic and embryologist. Tehran University of Medical Sciences Approved 2020-11-18 Ethic committee of Tehran University of Medical Sciences Deputy of research , First floor, Building number 1, Faculty of Medicine, Norethern entrance of Tehran University of Medical Science, Poursina Streat, Qods Street, Enghelab Street Tehran Tehran Iran (Islamic Republic of)