Investigation of the effect of oral melatonin on the thickness of the endometrium of infertile women in the IUI cycle

Determination of the effect of oral melatonin on the thickness of the endometrium of infertile women in the IUI cycle

A randomized clinical trial with two intervention groups, with parallel groups, without blinding, on 104 patients and the kitset.ir website was used for randomization.

104 infertile patients who referred to the women's clinic of Imam Sajjad Hospital in Yasuj and will undergo intrauterine sperm insemination(IUI) will randomly and without blinding divided into two groups:receiving melatonin and placebo (52 patients in each group).First, all patients are treated with clomiphene and letrozole, twice a day from the 3rd to the 7th day of menstruation, and then injectable gonadotropin injected on the 8th, 9th,and 10th days.If the thickness of the endometrium bu ultrasound is less than6 mm, 2 mg estradiol prescribe from the 8th day of menstruation.In the group with low endometrial thickness,6 mg melatonin prescribe and uterine endometrium thickness check again on the 11th and 14th day.On the 14th to 16th day of the cycle, if there are 1 to 2 suitable follicles, HCG ampoule is injected and 36 hours later IUI is performed.

Inclusion criteria: full consent to participate in the study, BMI less than 35, women with low endometrial thickness, no history of hospitalization and underlying diseases Exclusion criteria: male infertility, simultaneous uterine anomalies, fallopian tube blockage, having a history of endometriosis, AFC less than 10

The intervention group, 6 mg of melatonin and the control group, the placebo medicine which contains cellulose and will be similar to melatonin pills in terms of shape, size and taste will consume from the 3rd day of menstruation (daily) until the end of the cycle for one month before sleep and after 4 pm.

Endometrial thickness

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.