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IRCT20160410027311N6 IRCT 2018-04-30 Tabriz University of Medical Sciences The effect of selenium and vit E supplementation on Oogenesis improvement in infertile women with occult premature ovarian insufficiency: A randomized contorolled clinical trial The effect of selenium and vit E supplementation on anti-mullerian hormone (AMH) index and antral follicle count in infertile women with occult premature ovarian insufficiency: A randomized contorolled clinical trial 2018-05-04 anticipated 70 Complete https://irct.ir/trial/22404 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned 1 to 1 using the 4 and 6 block method right before the intervention begins, Blinding description: Blinding the allocation by a non-trafficker is done in the sampling and the received intervention (drug or placebo) is placed in the numbered blank opaque glasses, thus identifying the placement of the individuals. Glasses will be numbered from 1 to 70. The first person will be given the number one glass, and this will continue until the end of the sampling. N/A occult premature ovarian insufficiency. Intervention 1: Intervention group: The intervention group will receive one tablet of selenium 200 micrograms daily and one vitamin E 400 units per day for 90 days. Intervention 2: Control group: The control group will receive the plasebo of Selenium and vitamin E for 90 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no program for publishing participant data file
public Safiyeh Farhadi Dizaji
Midwifery Department, Nursing and Midwifery Faculty, South Shariati Street,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 s63farhadi@gmail.com Tabriz University of Medical Sciences scientific Behnaz Sadeghzadeh Oskouei
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 0364 sadeghzadehb@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Accepting informed written consent Women aged 20 to 40 years old Menstrual cycle Having two ovaries There is no evidence of endocrine disorders (diabetes, thyroid disorders, Addison's disease, etc.) by asking the patient and checking out the results of previous patient tests. Occult POI (hormone AMH <1 ng / ml, reduced ovarian reserve, less than 5 anthral follicles, reduced ovarian volume to less than 2.5 cubic centimeters, or all three cases) With BMI <30, the weight and height in this study will be measured by the researcher and the BMI will be calculated according to the formula below. BMI = (WEIGHT (kg)) / (LENGTH (m ^ 2)) 20 years 40 years Female Drug Addiction and Smoking The tendency to use donated eggs Having evidence of OVERT POI (FSH> 15 or amenorrhea for more than 3 months) Supplementation of selenium and vitamin E three months before the onset of intervention Having a history of radiotherapy and chemotherapy The use of anticoagulants (co-administration of vitamin E with these drugs increases the risk of bleeding) E28.3 Primary ovarian failure Treatment - Drugs Placebo Intervention group: The intervention group will receive one tablet of selenium 200 micrograms daily and one vitamin E 400 units per day for 90 days. Control group: The control group will receive the plasebo of Selenium and vitamin E for 90 days. Concentration of anti-mullerian hormone (AMH). Timepoint: Before the intervention begins and 12 months after the intervention begins. Method of measurement: To monitor the level of anti-mullerian hormone, blood sampling will be performed on the day of referral from the Brachial vein and will be immediately transferred to the laboratory and will be used with an ELISA kit. Number of ovarian antal follicles. Timepoint: Before the intervention begins and 12 months after the intervention begins. Method of measurement: Transvaginal ultrasonography of the ovary on the third day of the menstrual cycle, performed by a radiologist and a device for all participants to check the number of antral follicles. Ovarian volume. Timepoint: Before the intervention begins and 12 months after the intervention begins. Method of measurement: Ovarian volume with the same ultrasound on the third day of menstruation using the following formula Ovarian volume = Length × height × width × π / 6 It will be calculated for each ovary separately. The incidence of side effects of selenium and vitamin E and their placebo. Timepoint: After the end of the intervention. Method of measurement: The side effects of medicines will be questioned according to the checklist given during supplements or placebo and will be recorded in the checklist. Tabriz University of Medical Sciences Approved 2018-03-12 Ethics Committee of Tabriz University of Medical Sciences Azadi St., Golghast St., Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Deputy Directorate Tabriz East Azarbaijan Iran (Islamic Republic of)