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

Determining the relationship between astaxanthin consumption and plasma inflammatory factors Hs-CRP, IL-18, TNFα, -IL-6, IL-1b, NF-κB and, expression of genes related to endoplasmic reticulum pathway and apoptosis in Pbmc

This Triple-blind randomized clinical trial, controlled by placebo, based on the guidelines contained in the Helsinki Declaration, after obtaining permission from the ethics committee of Tehran University of Medical Sciences, 501 patients will be recruited. Prior to the intervention, written informed consent will be obtained from all participants

The location of the experiment:Tehran University of Medical Sciences. Sampling location: Omid fertility center. Isolation of blood serum and measurement of inflammatory factors - Isolation of pripheral blood mononuclear cells (Pbmc)- Assessment of the expression of ER stress and apoptotic pathway genes in pbmc;

Inclusion criteria: patients with PCOS-induced infertility at the age of 18-40 years. Exclusion criteria: pregnancy; adrenal hyperplasia; androgen-secreting tumors; hyperprolactinemia; thyroid dysfunction; diabetes or glucose tolerance disorder and male infertility factors.

Astaxanthin consumer. Placebo consumer.

Plasma inflammatory factors include Hs-CRP, IL-18, IL-6, TNF-α, IL-1β and NF-κB; Endoplasmic reticulum stress pathway and apoptosis genes in Pbmc: ATF4, ATF6, XBP1, GRP78, CHOP, DR5, BCL2, BAX.Caspase8

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.

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.

All data obtained in the research will be published in one of the valid and related scientific journals.

2023

Researchers working in academic institutions

The data of this study can be used as an adjuvant therapy in patients with polycystic ovary syndrome underwent IVF/ICSI.

Masoome jabarpour

By sending an email to the corresponding author.