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IRCT20181225042109N1 IRCT 2019-05-09 Sanandaj University of Medical Sciences The effect of Myo-inositol on pregnancy success The effect of Myo-inositol on pregnancy success in women with IVF/ICSI cycle 2019-05-22 anticipated 70 Complete https://irct.ir/trial/36246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher goes to the clinic daily. Each patient who has inclusion criteria to enroll in the study is considered as a sample. Samples are divided into 2 groups A and B by computer random selection.Patients are randomly divided into two intervention and control groups based on randomized block method, for example: ABAB / AABB / BBAA, Blinding description: Women in the study and outcome assessors are unaware of how they are grouped. The appearance of the drug will be the same for both intervention and control groups. 3 Female infertility. Intervention 1: Intervention group: Administration of 2000 mg myo-inositol plus 200 mg of folic acid daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital since the onset of an agonist cycle or embryo transfer for 2 months. Intervention 2: Control group: Administration of placebo daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital at the onset of an agonist cycle or embryo transfer for 2 months. Yes - There is a plan to make this available What will be shared: Part of the data on the primary outcome is for sharing. When: One year after the publication the data will be available. To whom: Researchers working in academic and scientific institutions. Conditions: Meta-analysis is allowed on the data of this study. Where to obtain: Dr. Shahin Abbasi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran,Email: s.abbasi@muk.ac.ir How to obtain: After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email . Comments:
public Shahin Abbasi
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3366 4673 s.abbasi@muk.ac.ir Sanandaj University of Medical Sciences scientific Fariba Seyedoshohadaie
Keshavarz St, Besat Hospital, sanandaj, Iran
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3328 5910 f.seyedoshohadaei@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Infertility for at least one year Not using contraception Candidates for IVF / ICSI Minimum age of 20 years and a maximum of 40 years Agonist cycles having a regular menstrual cycle (24-35 days) 20 years 40 years Female Underlying disease Uterine Anomaly Freeze embryo transfer cycle History of repeated abortions Women with any underlying diseases such as metabolic or endocrine disorders and uterine anomaly N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: Administration of 2000 mg myo-inositol plus 200 mg of folic acid daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital since the onset of an agonist cycle or embryo transfer for 2 months Control group: Administration of placebo daily to ICSI / IVF candidate patients referring to the Infertility Clinic of Besat Hospital at the onset of an agonist cycle or embryo transfer for 2 months. The number and quality of oocytes obtained. Timepoint: Two weeks after the intervention. Method of measurement: Using Sonography. Number and quality of embryos formed. Timepoint: Third week after intervention. Method of measurement: Using Sonography. Number of clinical pregnancy. Timepoint: Clinical pregnancy was defined as a fetal cardiac activity in the 6th to 7th week of pregnancy. Method of measurement: Sonography. Miscarriage. Timepoint: Pregnancy loss earlier than the 20th week of gestation. Method of measurement: Observation and sonography. Preterm delivery. Timepoint: It was measured during the pregnancy. Definition: Birth of the baby earlier than 37wk of the pregnancy. Method of measurement: Observation and sonography. Live birth. Timepoint: At the end of pregnancy. Method of measurement: Observation. Sanandaj University of Medical Sciences Approved 2018-12-02 Ethics committee of Kurdistan University of Medical Sciences Pasdaran St., Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)