Evaluation of the Effect of Melatonin on the Follicular Oxidative Stress and Quality of Oocyte and Embryo in Women with Diminished Ovarian Reserve

Diminished ovarian reserve (DOR) significantly decreases the success rate of Assisted Reproductive techniques (ART). In this study we study the effect of melatonin on the follicular oxidative stress and quality of oocyte and embryo in women with Diminished ovarian reserve .

This study is a randomized, double-blind, placebo-controlled clinical trial.

In this research, an intervention group including 38 patients with reduced ovarian reserve (based on entry and exit criteria) three months after taking one melatonin tablet (3 mg melatonin tablet Hakim) per day and a control group that received a placebo.The patient and the doctor do not know the contents of the package (melatonin tablets and placebo).

ART for the first time, normal male factor, normal uterine cavity and presence of two of the three following criteria first; summation of bilateral AFC ≤ 6, second; AMH≤1 and third; basal FSH on the 3rd day of menstrual cycle≥10. If the couple decline to participate, the protocol is not exactly followed or the ovaries showed poor responses to gonadotropins the cases are excluded from the study.

In the case group ,the paitent recieve melatonin by does of 3 mg/day from 5'th day of sycle till pick-up day.in the control group ,the paitent recieve pelacebo capsule one every night from 5'th day of sycle till pick-up day .

The main outcomes in this plan arethe level of sex hormones, the number of follicles, the number and quality of oocytes and embryos, measuring the level of superoxide dismutase, the expression of GDF9 (Growth Differentiation Factor 9), and BMP15(Bone Morphogenetic Protein 15) and (nuclear factor erythroid 2–related factor 2)NRF -2genes which will be measured before and after the intervention.

Individuals will be randomly assigned to one of two study groups with the help of a random number table and will receive the intervention of the allocated group. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the study, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.

This study is a randomized, double-blind, placebo-controlled clinical trial. In this research, an intervention group including 38 patients with reduced ovarian reserve (based on inclusion and exclusion criteria) three months after consuming one melatonin pill (Melatonin 3 mg Hakim pill) per day and a control group receiving a placebo (placebo) Figure by Department of Pharmacy, Urmia University of Medical Sciences) suffering from reduced ovarian reserve, referred to the infertility center of Kausar Hospital, Urmia, enter the cycle of ovulation stimulation.