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IRCT20160722029027N8 IRCT 2019-07-27 Vice Chancellor for research of Shahid Beheshti University of Medical Sciences Effects of Myo-inositol in poor responder patients undergoing intracytoplasmic sperm injection Effects of Myo-inositol on IVF outcomes in poor responders undergoing intracytoplasmic sperm injection and comprission with folic acid:a randomised clinical trial 2016-04-20 anticipated 148 Complete https://irct.ir/trial/23423 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects were assigned into two groups, using permuted block randomization method with size of block of two. Package block rand in R statistical software was used for preparing randomization list, Blinding description: this is a double-blinded study in which both patients and the conductor specialist were blinded about the contents of dug boxes. Each of drug boxes contains either Myo-inositol powder and placebo tablet (group A) or folic-acid tablet and placebo powder (group B). Neither specialist nor patients were informed about the boxes contents, just the drug company was informed about the study groups. Specialist assigned patients to one of these boxes according to the randomization list. In order to blind patients, no names was typed on the tablet or powder container. 2 Noninflammatory disorders of female genital tract. Intervention 1: Intervention group: Myoinositol 4 gr and Folic Acid 400 microgram was administered one month before the cycle and ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle. Intervention 2: Control group: Placebo and Folic Acid 400 microgram was administered one month before the cycle and ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle. Yes - There is a plan to make this available What will be shared: تعداد اووسیت -دوز گنادوترو پین مصرفی When: without restriction To whom: All researchers Conditions: With permission from the author responsible Where to obtain: With permission from the author responsible How to obtain: ٍEmail to author responsible Comments: Effective drug in IVF
public Leila Nazari
Taleghani hospital, Yaman st, Velenjak, Chamran highway
Tehran Iran (Islamic Republic of) 198571741398 +98 21 2243 2558 nazari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Saghar Salehpour
Taleghani hospital, Yaman st, Velenjak, Chamran highway
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2558 saghar.salehpour2014@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age below 45 years Body mass index (BMI) between 20-30 low ovarian reserve [both ovarian AFC below 7 or AMH below 1.1 ng/ml or low ovarian response in previous cycle (below 3 oocyte) none history of allergy to Myo-inositol no limit 45 years Female unwillingness to continue N98.9 Complication associated with artificial fertilization, unspecified Treatment - Drugs Placebo Intervention group: Myoinositol 4 gr and Folic Acid 400 microgram was administered one month before the cycle and ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle Control group: Placebo and Folic Acid 400 microgram was administered one month before the cycle and ovarian stimulation with antagonist protocol will be started on day 2 or 3 of menstrual cycle Number of metaphase II oocyte. Timepoint: Time of oocyte pick up. Method of measurement: According to embryolog criteria. Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Serum βHcG test. Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: Transvaginal ultrasound. Ongoing pregnancy. Timepoint: 10 weeks after embryo transfer. Method of measurement: Vision fetal heart beat in ultrasound. Vice Chancellor for research of Shahid Beheshti University of Medical Sciences Approved 2016-04-19 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjak, Yaman St, Chamran highway Tehran Tehran Iran (Islamic Republic of)