]>
IRCT20201029049183N2 IRCT 2022-04-12 Tehran University of Medical Sciences Effect of Astaxanthin in treatment of PCOS The Astaxanthin effect on serum inflammatory markers and expression of genes related to ER stress and apoptosis pathway in peripheral blood mononuclear cell in polycystic ovary syndrome women 2022-04-21 anticipated 60 Complete https://irct.ir/trial/62804 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be randomly assigned to the study after visiting the gynecology clinic. Randomization will be in the form of blocking in such a way that the method of replacement blocks is used within each floor. The blocks will be binary, consisting of AB and BA. The randomization tool will be a table of random numbers, that using the sequence AB for numbers zero through 4 in the random number table and the sequence BA for 5 to 9.It should be noted that the letter A means the intervention group and the letter B means the control group For hiding we use concealment allocation in a way that before the individual is assigned, the assigned group is not specified. In this method, each of the random sequences created on a cards are placed in the closed envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the time of registration of participants, based on the order of entry of the eligible participants in the study, one of the closed envelopes will be opened and the assigned group of the participant will be revealed, Blinding description: This study will be a three-way blind and the patient, researcher and statistical analyst of the patients' group therapy have no information and the decoder is outside the research team. The drug under study (Astaxanthin) and placebo in a completely similar shape and appearance, each of which is 60 in the same bottle instead of the drug will be provided to the subjects based on random allocation. It should be noted that the drug content of each The bottles are code-tagged on the bottles by the by someone outside the research team consultant and the research team is not aware of their interpretation. 3 Polycystic Ovarian Syndrome. Intervention 1: Intervention group: Intervention group: Astaxanthin consumption. In this group, patients take 12 mg of astaxanthin daily ( in 2 capsules of 6mg twice in the morning and at night) for 60 days. Their routine treatment, metformin, does not stop. Intervention 2: Control group: Placebo consumption. In this group, patients take 12 mg of placebo daily ( in 2 capsules of 6mg twice in the morning and at night) for 60 days. Their routine treatment does not stop with metformin. Yes - There is a plan to make this available What will be shared: All data obtained in the research will be published in one of the valid and related scientific journals. When: 2023 To whom: Researchers working in academic institutions Conditions: The data of this study can be used as an adjuvant therapy in patients with polycystic ovary syndrome underwent IVF/ICSI. Where to obtain: Masoome jabarpour How to obtain: By sending an email to the corresponding author. Comments:
public dr.fardin amidi
Poursina St. School of Medicine, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3411 amidifardin@yahoo.com Tehran University of Medical Sciences scientific Dr. Fardin Amidi
Poursina St. School of Medicine, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6405 3411 amidifardin@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Oligo/anovulation (ovulationabnormality) Hyperandrogenism Polycystic ovaries on ultrasound 18 years 40 years Female Pregnancy Adrenal hyperplasia Androgen-secretingtumors Hyperprolactinemia Thyroid dysfunction Diabetes mellitus or glucose tolerance Male infertility factors E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: Intervention group: Astaxanthin consumption. In this group, patients take 12 mg of astaxanthin daily ( in 2 capsules of 6mg twice in the morning and at night) for 60 days. Their routine treatment, metformin, does not stop. Control group: Placebo consumption. In this group, patients take 12 mg of placebo daily ( in 2 capsules of 6mg twice in the morning and at night) for 60 days. Their routine treatment does not stop with metformin. ER stress and apoptotic factor. Timepoint: Before and 60 days after the intervention. Method of measurement: real time pcr. Plasma inflammatory factors. Timepoint: Before and 60 days after the intervention. Method of measurement: ELISA KIT. Tehran University of Medical Sciences Approved 2021-12-11 Ethics committee of Tehran University of Medical Sciences Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St Tehran Tehran Iran (Islamic Republic of)