Objective: Diminished ovarian reserve (DOR) significantly decreases the success rate of Assisted Reproductive techniques (ART). In this study we study the effect of melatonin on ART outcomes of the women with DOR.
Methods: This project performe on the infertile women who were referred to the infertility center in Mother and Child Hospital, affiliated to Shiraz University of Medical Sciences for 12 months in 80 patients. Inclusion criteria were: 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. The double blind nature of the study is explained to the couples, 40 patients are taking melatonin and the other take placebo. 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.
Capsules containing 3 mg Melatonin and placebo with the same shapes. The patients or the clinicians do not know that which package contained placebo or melatonin. The subjects recommende to take one capsule every night orally before going to bed starting from the 5th day of the menstrual cycle prior to the cycle that is planned for gonadotropin stimulation. Transvaginal ultrasound Scan (TVUS) performe for all of the participants before starting the supplement and they were recommended to continue the supplement up to the time of ovum pickup. Down regulation protocol is used for all patients by subcutaneous injection of GnRH agonists, starting since the 21th day of the same cycle that melatonin was started. Ovarian response to gonadotropin stimulation was monitored by TVUS starting from the 7th day and measurement of serum estradiol (E2) levels every 3 days. Final oocyte maturation trigger by 10000 IU hCG when at least 2 follicles reached 17–18 mm diameter. Oocyte retrieval was performed 34–36 h after triggering. Luteal phase was supported by 100mg intramuscular progesterone daily, from the day of oocyte retrieval for three days and was continued by vaginal progesterone once daily.
The patients were followed and the cycle outcomes were documented. After gathering all data, the code numbers of the packages will be broken by the pharmaceutics and data analyze. The case and control groups are compared for the outcomes such as; duration of stimulation, dosage of gonadotropins, serum E2 level on the triggering day, number and quality of oocytes and embryos, clinical pregnancies and miscarriages .