Investigating the effect of auriculotherapy on the hormonal and clinical indicators of infertile women with polycystic ovary syndrome (PCOS)

Determining the effect of auriculotherapy on hormonal and clinical indicators of infertile women with polycystic ovary syndrome

A double-blind, two-group, randomized clinical trial with random selection from the envelopes corresponding to the numbers of the intervention and placebo groups on 70 participants.

Participants in the intervention group will be treated over 3 menstrual cycles in a private room at a clinic in Isfahan, starting after the end of bleeding for 12 sessions (4 sessions every 5 days). Points on the pituitary, ovaries, uterus, pelvis, endocrine system, master shoulder, Shen Men, thalamic, and relax will be stimulated using a Plus Excel 2 pointer followed by a seed, and patients should press the seeds for one minute every hour. The placebo group will receive non-functional device stimulation and false seed stimulation without pressure. After the intervention, questionnaires will be given again to both groups.

primary infertility, NL spermogram, no use of clomiphene or letrozole, ovulatory dysfunction, no uterine abnormalities, no uncontrolled underlying conditions, BMI 18.5- 29.9, no use of medications or complementary methods in the past 3 months, , no inflammation in the ears, and depression, anxiety, and stress scores below 21, 15, and 26, respectively.

In the intervention group, participants receive auriculotherapy for 12 sessions over 3 menstrual cycles. In the placebo group, points are stimulated with a non-functional device without pressure and are falsely stimulated.

Duration of menstrual cycle; Hirsutism; Acne; Menstrual irregularity; Mean levels of sex hormones (E2, DHEAS, free Testosterone, Total Testosterone, FSH, LH, AMH); Mean ultrasound findings (number of follicles, follicle size, ovary size, endometrial thickness); βHCG.

For this purpose, envelopes are used in the following manner: an equal number of identical envelopes in design and material are prepared corresponding to the number of participants in the study. Then, even and odd numbers (from 1 to 70) are written inside each envelope. Envelopes containing even numbers are assigned to the auriculotherapy group, while envelopes with odd numbers are assigned to the placebo group.

In this study, double-blinding means that neither the participants nor the individual collecting the data are aware of the allocation of patients to the intervention or placebo groups. This process is carried out as follows: a trained individual independent of the research team is responsible for distributing and collecting the questionnaires and scoring them. During the allocation phase, sealed envelopes containing even and odd numbers are randomly given to the patients. Even numbers indicate assignment to the auriculotherapy group, while odd numbers indicate the placebo group. These envelopes are distributed only by the trained individual, and their contents remain unknown to both the participants and the data collector. This method ensures that none of the parties involved in the study know which patient belongs to which group, preventing any potential bias and ensuring impartiality and accuracy in the results.

The main results of the study will be shared.

Data access starts 6 months after results are published.

Academic researchers

For the knowledge and use of other researchers in their next similar studies

For correspondence regarding this study, please contact the responsible individual, Dr. Valiani, via email at valiani@nm.mui.ac.ir.

After sending the request from the applicant, the email will be checked and after confirming the purpose of accessing the data, the responsible person will respond to the request as soon as possible.