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IRCT20220809055652N1 IRCT 2023-09-22 Kashan University of Medical Sciences The effect of inositol on fertility in Frozen embryo transfer cycles in Poly cystic ovary syndrome The effect of inositol on fertility in Frozen embryo transfer cycles in Poly cystic ovary syndrome 2022-10-02 anticipated 60 Complete https://irct.ir/trial/65214 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: It will be done by simple random method and using lottery. Each patient will receive a number or code. We will write the numbers on pieces of paper. Then we will put the pieces of paper in a container and select the samples for the intervention and control groups according to the sample size from the numbers obtained from the lottery, Blinding description: According to coordination with the pharmacy of Shahid Beheshti Hospital in Kashan, the considered drugs are provided to the patients in two packages A and B. Patients in the control group will receive package A, which includes their routine medications, plus folic acid, which is produced with a similar appearance by a reputable pharmaceutical company, and patients in the intervention group will receive package B, which includes their routine medications plus inofolic. 3 Polycystic ovarian syndrome. Intervention 1: Control group: Control group: According to coordination with the pharmacy of Shahid Beheshti Hospital in Kashan, the drugs considered in this study are provided to the patients in two packages A and B. Patients in the control group received Package A, which included their own routine medications plus folic acid manufactured in a similar form by a reputable pharmaceutical company. These patients take folic acid for 8 weeks before the embryo transfer date, and then the embryo transfer is done with a suitable quality and the biochemical pregnancy rate (slight and temporary increase in B-hCG level), Clinical Pregnancy rate (observation of the fetus with activity heart in 6-7 weeks of pregnancy) and the rate of spontaneous abortion (pregnancy loss in 5-12 weeks of pregnancy) will be investigated in this group. Intervention 2: Intervention group: According to coordination with Shahid Beheshti Kashan hospital pharmacy, the drugs considered in this study are provided to the patients in two packages A and B. Patients in the intervention group will receive package B, which includes their routine medications along with inofolic. The patients of the intervention group received these drugs for eight weeks and then the embryo transfer was done with good quality and the amount of biochemical pregnancy (slight and temporary increase in B-hCG level), the amount of clinical pregnancy (observation of the fetus with cardiac activity in 6 weeks) 7-pregnancy) and the rate of spontaneous abortion (pregnancy loss in 5-12 weeks of pregnancy) will be investigated in this group. 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 "No more information"
public Zohreh Talebi Mazreshahi
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd, Kashan, Isfahan province, Iran. Post code:8715988111
Kashan Iran (Islamic Republic of) 8715988111 +98 31 5558 9258 talebi-z@kaums.ac.ir Kashan University of Medical Sciences scientific Zohreh Talebi Mazreshahi
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd, Kashan, Isfahan province, Iran. Post code:8715988111
Kashan Iran (Islamic Republic of) 8715988111 +98 31 5558 9258 talebi-z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) People with polycystic ovary syndrome based on sonographic and laboratory findings. Ages between 20 and 40 years old Candidate to enter the FET procedure at Infertility Center of Shahid Beheshti Hospital, Kashan, based on infertility records. 20 years 40 years Female People with uterine abnormalities (such as Asherman's syndrome, fibroids, polyps and adenomyosis diagnosis) Inositol contraindications Treatment cycles with embryo donation or prenatal genetic screening, The mother is over 40 years old Endometriosis Unexplained Infertility E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Control group: Control group: According to coordination with the pharmacy of Shahid Beheshti Hospital in Kashan, the drugs considered in this study are provided to the patients in two packages A and B. Patients in the control group received Package A, which included their own routine medications plus folic acid manufactured in a similar form by a reputable pharmaceutical company. These patients take folic acid for 8 weeks before the embryo transfer date, and then the embryo transfer is done with a suitable quality and the biochemical pregnancy rate (slight and temporary increase in B-hCG level), Clinical Pregnancy rate (observation of the fetus with activity heart in 6-7 weeks of pregnancy) and the rate of spontaneous abortion (pregnancy loss in 5-12 weeks of pregnancy) will be investigated in this group. Intervention group: According to coordination with Shahid Beheshti Kashan hospital pharmacy, the drugs considered in this study are provided to the patients in two packages A and B. Patients in the intervention group will receive package B, which includes their routine medications along with inofolic. The patients of the intervention group received these drugs for eight weeks and then the embryo transfer was done with good quality and the amount of biochemical pregnancy (slight and temporary increase in B-hCG level), the amount of clinical pregnancy (observation of the fetus with cardiac activity in 6 weeks) 7-pregnancy) and the rate of spontaneous abortion (pregnancy loss in 5-12 weeks of pregnancy) will be investigated in this group. Fertility rate. Timepoint: Two months. Method of measurement: Clinical examination of pregnancy with the criterion of fetal heart observation in ultrasound. Kashan University of Medical Sciences Approved 2022-07-26 Ethics Committee in Research of Faculty of Medicine, Kashan University of Medical Sciences Faculty of Medicine, Kashan University of Medical Sciences, Qotb-e Ravandi Blvd, Kashan, Isfahan province, Iran. Post code:8715988111 Kashan Isfehan Iran (Islamic Republic of)