Investigating the effect of levothyroxine therapy on sex hormone levels in women with subclinical Hypothyroidism.

Determination of the effect of levothyroxine therapy on sex hormones in women with subclinical hypothyroidism

The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized

This study was conducted to evaluate the effect of levothyroxine therapy on the level of sex hormones in women with subclinical hypothyroidism in the clinic of Vaseji Hospital in Sabzevar. Clinical observant and participants will be unaware of how they are grouped. Patients will be randomized in the intervention group (levothyroxine) and in the control (placebo). The response to treatment is evaluated by ELISA at the end of the second month after the intervention for both groups.

Inclusion criteria: Women aged 17-40 years with TSH above the maximum normal laboratory range and less than 10 and also T3, T4 normal. Exclusion criteria: Irregular ovarian cycles (irregular menstruation) Pregnancy, breastfeeding, hypothalamic amenorrhoea, known pituitary diseases, and early menopause. The history of ovarian surgery, polycystic ovary syndrome (PCOS), and the use of hormonal medications History of levothyroxine tablets in the last two months Dissatisfaction patients to participate in the study.

Intervention group: Patients in this group were treated with levothyroxine (50 micrograms daily and 5 days a week fasting) with the aim of Euthyroidism. Control group: Patients in this group were treated with placebo for two months (fasting 5 days a week).

Determination of Estrogen and Progesterone levels

Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly, 20 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with Levothyroxine and Placebo tablet, respectively. First, we determine all foursome modes in which half of the individuals are assigned to group A and the other half to group B. Then we assign one of the digits 1 to 6 to each of the foursome combinations (which includes six modes). In the next step, we must randomly select 20 blocks of four and write their combinations in succession. For this we have to make 20 samplings with replacement from a six-member community; 20 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block).

Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The clinical observant and the participants are unaware of the groups. It should be noted that levothyroxine and placebo tablet have been similar in appearance, color, and packaging.