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IRCT20170529034209N2 IRCT 2022-11-15 Oroumia University of Medical Sciences Effect of Melatonin onImproving Fertility in Women with Diminished Ovarian Reserve DOR Evaluation of the Effect of Melatonin on the Follicular Oxidative Stress and Quality of Oocyte and Embryo in Women with Diminished Ovarian Reserve 2022-12-01 anticipated 38 Complete https://irct.ir/trial/66421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients are advised to take one pill every night before going to sleep from the night of menstruation until the oocyte retrieval is done. Before starting the study, ultrasound will be done to evaluate the ovary. All patients start the gonadotropin-releasing hormone agonist protocol from day 21 of the same cycle. After 7 days, an ultrasound is performed and the level of estradiol is measured, which is repeated every 3 days, and when we have at least two eggs of 17-18 mm, 10,000 units of human chorionic gonadotropin are injected. 34 to 36 hours later, egg maturation occurs when 100 mg of progesterone intramuscular injection is performed to support the luteal phase and continues vaginally. Patients are followed up and their results are recorded. Then, after opening the codes, the data is analyzed. The patient and control groups are compared in terms of duration of stimulation, gonadotropin dose, estradiol level on the day of the trigger, the number and quality of eggs and embryos, and chemical or clinical pregnancy.The first group (treatment): women with reduced ovarian reserve treated with melatonin who enter the cycle of ovulation stimulation after three months of supplementation. The second group (control): women with reduced ovarian reserve who enter the cycle of ovulation stimulation. They will be divided. After selecting the subjects to be studied, the work steps will be carried out in the following order: 1. Measurement of serum levels of FSH, LH and E2 hormones in the control group and the treatment group before and three months after taking melatonin2. Measurement of the serum level of FSH, LH and E2 hormones in the treatment group before ovulation stimulation 3. Beginning of ovulation stimulation courses according to the protocols of the infertility center of Kosar Hospital in Urmia 4. Examining the number of follicles in all groups 5. Oocyte collection from all groups according to the protocols of the infertility center of Kausar Hospital in Urmia 6. Investigating the number and quality of oocytes obtained from ovarian stimulation using a stereomicroscope7. Preparation of samples of granulosa cells and follicular fluid 8. Measurement of superoxide desmutase level in follicular fluid by spectrophotometric method using SOD Assay Kit9. Measuring NRF2 gene expression as a marker of oxidative stress suppression and GDF9 and BMP15 genes as markers of oocyte maturation in granulosa cells by qRT-PCR10 method. Measuring the quality of embryos obtained on the third and fifth day, Randomization description: 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, Blinding description: 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. 2-3 Diminished ovarian reserve (DOR). The intervention group of 38 patients with Diminished Ovarian Reserve (based on Inclusion and exclusion criteria) three months after taking one melatonin tablet (3 mg melatonin tablet Hakim) per day.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Hojjat Ghasemnejad- berenji
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
Urmia Iran (Islamic Republic of) 5715833631 +98 44 3346 5079 Ghasemnejadberenji.h@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Hojjat Ghasemnejad- berenji
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
Urmia Iran (Islamic Republic of) 5715833631 +98 44 3346 5079 Ghasemnejadberenji.h@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) ART for the first time normal uterine cavity 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. 25 years 50 years Female If the couple decline to participatestudy the protocol is not exactly followed the ovaries showed poor responses to gonadotropins the cases E28.3 Primary ovarian failure Treatment - Drugs The intervention group of 38 patients with Diminished Ovarian Reserve (based on Inclusion and exclusion criteria) three months after taking one melatonin tablet (3 mg melatonin tablet Hakim) per day. Number of ovum have received in each IVF cycle. Timepoint: On day of ovum pick up. Method of measurement: Measuring number of ovumes on the day of pick up in lab by the embryologist under microscope (GV , MI , MII ) and quality of emberyo also by the same pathologist due to kind of cell division ( Grade I , II , III , IV). Quality of ovum have received in each IVF cycle. Timepoint: On day of ovum pick up. Method of measurement: evaluation quality of ovumes on the day of pick up in lab by an embryologist under the microscope (GV , MI , MII ) and quality of embryo also by the same pathologist due to kind of cell division ( Grade I , II , III , IV). Quality of emberyo have received in each IVF cycle. Timepoint: On day of emberyo insercion (IVF). Method of measurement: quality of emberyo on the day of pick up in lab by pathologist under microscope (GV , MI , MII ) and quality of emberyo also by the same pathologist due to kind of cell division ( Grade I , II , III , IV). Expression of the GDF9,BMP15, NRF -2 genes. Timepoint: On day of ovum pick up. Method of measurement: QRT-PCR. Superoxide dismutase enzyme. Timepoint: On day of ovum pick up. Method of measurement: spectrophotometry. The level of luteinizing hormone (LH),FSH,E2. Timepoint: menstrual cycle. Method of measurement: ELISA. Clinical pregnancy. Timepoint: 4 – 6 weeks after emberyo transfering. Method of measurement: Serum BHCG and TVS. Oroumia University of Medical Sciences Approved 2022-09-21 Ethics Committee of Urmia University of Medical Sciences Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran urmia West Azarbaijan Iran (Islamic Republic of)