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IRCT20221127056633N1 IRCT 2023-04-03 Yasouj University of Medical Sciences The effect of melatonin on endometrial thickness Investigation of the effect of oral melatonin on the thickness of the endometrium of infertile women in the IUI cycle 2023-04-09 anticipated 104 Complete https://irct.ir/trial/67282 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used, in which the randomization unit is individual, and the random sequence generation software (Random Number Generator software) is used, and for the purpose of concealment, the concealment of random allocation is used. By using opaque letter envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order.In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. 3 Infertility. Intervention 1: Intervention group: In this group, 6 mg of melatonin which is prepared by Razak Pharmaceutical Company will be consumed from the 3rd day of menstruation (daily) until the end of the cycle for one month, before going to bed and from 4 pm onwards. Intervention 2: Control group: In this group, the placebo, which contains cellulose and will be similar to melatonin pills in terms of shape, size and taste and it is prepared by Razak Pharmaceutical Company, is consumed from the 3rd day of menstruation (daily) until the end of the cycle for one month, before going to bed and from 4 pm onwards. 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 It has not been decided yet.
public Shahin Taj Aramesh
Yasuj University of Medical Sciences, Shahid motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad province, Iran.
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3333 7251 sh.aramesh@gmail.com Yasouj University of Medical Sciences scientific Shahin Taj Aramesh
Yasuj University of Medical Sciences, Shahid motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad province, Iran.
Yasuj Iran (Islamic Republic of) 7591741417 +98 71 3837 0829 sh.aramesh@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Full consent to participate in the study BMI less than 35 Women with low endometrial thickness No history of hospitalization and underlying diseases 18 years 42 years Female Male infertility Simultaneous uterine anomalies Obstruction of uterine tubes Having a history of endometriosis AFC less than 10 N97 Female infertility Treatment - Drugs Placebo Intervention group: In this group, 6 mg of melatonin which is prepared by Razak Pharmaceutical Company will be consumed from the 3rd day of menstruation (daily) until the end of the cycle for one month, before going to bed and from 4 pm onwards. Control group: In this group, the placebo, which contains cellulose and will be similar to melatonin pills in terms of shape, size and taste and it is prepared by Razak Pharmaceutical Company, is consumed from the 3rd day of menstruation (daily) until the end of the cycle for one month, before going to bed and from 4 pm onwards. Endometrial thickness. Timepoint: Measurement of endometrial thickness at the beginning of the study and 11 and 14 days after starting melatonin. Method of measurement: Ultrasound sonography. Yasouj University of Medical Sciences Approved 2022-11-25 Ethics Committee of Yasouj University of Medical Sciences Deputy of research and technology of Yasuj University of Medical Sciences, Shahid motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad province, Iran. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)