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IRCT20140818018842N17 IRCT 2020-01-05 Deputy of Research and Technology, Tehran University of Medical Sciences. Effect of treatment by OCP on infertility in PCOD patients The randomized, single -blinded clinical trial comparing OCP effect before frozen embryo transfer versus gonadotropin – releasing hormone agonist injection on improving the outcome of pregnancy in infertile patients with hyper androgenic poly-cystic ovary syndrome in the IVF/ICSI cycle 2018-10-23 anticipated 120 Complete https://irct.ir/trial/44532 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups A (OCP receiver) and B (GNRH agonist receiver). In this study, neither the participants nor the researchers know which participants belong to the placebo group, nor the intervention group. Only after all data have been recorded do the person not involved in the study, Blinding description: The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups A (OCP receiver) and B (GNRH agonist receiver). In this study, neither the participants nor the researchers know which participants belong to the placebo group, nor the intervention group. Only at the end of the study, the results are reported by a person not involved in the study. 3 Patients with hyper androgenic polycystic ovarian disease. Intervention 1: Intervention group: Receive of the OCP (Rokinz LD), daily 2 months before frozen- thawed embryo transfer. Intervention 2: Control group: Receive depot preparation of the GNRH agonist (Luprolide acetate 3.75 mg) before frozen- thawed embryo transfer, one dose every 4 weeks, totally two doses. Yes - There is a plan to make this available What will be shared: All data is published after being unidentified. When: starting 24 months after publication. To whom: Infertility researchers. Conditions: Submith a valid academic Certificate. Where to obtain: Send email to: hamed_m97@yahoo.com How to obtain: Receive the data at least 3 month later. Comments:
public Shima Tavakolian
Tehran University of Medical Science. Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417653761 +98 21 84901 asamaei@razi.tums.ac.ir Tehran University of Medical Sciences scientific Shima Tavakolian
Tehran University of Medical Science. Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417653761 +98 21 84901 asamaei@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Oligo ovulation or anovulation. Clinical and/or biochemical signs of hyper- androgenism. Polycystic ovaries. 20 years 45 years Female Patients with hyper- anderogenism caused by hormonal drugs or other medications. Patients who have known sever organ dysfunction or mental illness. Pregnant women or being in Post- miscarriage period. breastfeeding. being in the 6 week postpartum period. Patients had congenital adrenal hyperplasia or were suspected of having Cushing s syndrome or an androgen – screening neoplasm. Female inf N97.0 Treatment - Drugs Treatment - Drugs Intervention group: Receive of the OCP (Rokinz LD), daily 2 months before frozen- thawed embryo transfer. Control group: Receive depot preparation of the GNRH agonist (Luprolide acetate 3.75 mg) before frozen- thawed embryo transfer, one dose every 4 weeks, totally two doses. Endometrium thickness. Timepoint: Before starting treatment and embryo transfer. Method of measurement: Trans vaginal ultra-sonography. The number of positive chemical pregnancy test. Timepoint: 14 days after embryo transfer. Method of measurement: Laboratory test (BHCG over than 40 IU). The number of successful clinical pregnancy. Timepoint: 6 to 8 weeks after embryo transfer. Method of measurement: Fetal Heart in Trans vaginal ultrasonography. Miscarriage rate. Timepoint: Abortion before 12 weeks of pregnancy. Method of measurement: Fetal death before 12 weeks in ultrasonography. Live birth rate. Timepoint: At 28th week of pregnancy. Method of measurement: Trans abdominal ultrasonography. Deputy of Research and Technology, Tehran University of Medical Sciences. Approved 2018-11-10 Ethics Committee of Tehran University Medical Sciences Ethics Committee of Tehran University of Medical Sciences, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)