]>
IRCT20091219002889N15 IRCT 2024-11-06 Esfahan University of Medical Sciences effect of auriculotherapy on the hormonal and clinical indicators of infertile women Investigating the effect of auriculotherapy on the hormonal and clinical indicators of infertile women with polycystic ovary syndrome (PCOS) 2024-11-09 anticipated 70 Complete https://irct.ir/trial/79681 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A PCOS. Intervention 1: Intervention group: In this study, auriculotherapy is used as a non-invasive and side-effect-free treatment method. This approach is based on stimulating specific points on the ear using the "Pointer Plus Excel II" device and placing seeds on these points. The stimulated points include the pituitary, ovary, uterus, pelvis, endocrine, master shoulder, Shen Men, thalamic, relax, and ectoderm points. By stimulating these points, signals are sent to the brain to regulate the body's physiological functions.The auriculotherapy session schedule consists of three menstrual cycles. Starting from the end of menstrual bleeding, each cycle includes four auriculotherapy sessions (every five days), with a total of 12 sessions for each participant. The seeds remain on the ear points for five days and are replaced during the participants' next visit.Participants are advised to press the seeds for one minute every hour throughout the day (except during sleep) to maximize the stimulation effects. Showering while the seeds are on the ears does not interfere with treatment, and reminder calls may be made to encourage participants to press the seeds regularly.After completing the auriculotherapy sessions, assessments (covering clinical, hormonal, and sonographic symptoms of PCOS, as well as depression, stress, and anxiety) are conducted immediately after the intervention and again three months post-intervention. Intervention 2: Control group: In the placebo group, points are stimulated falsely without activating the device (and without pressure from the device on the points), and then treated without actual stimulation. Yes - There is a plan to make this available What will be shared: The main results of the study will be shared. When: Data access starts 6 months after results are published. To whom: Academic researchers Conditions: For the knowledge and use of other researchers in their next similar studies Where to obtain: For correspondence regarding this study, please contact the responsible individual, Dr. Valiani, via email at valiani@nm.mui.ac.ir. How to obtain: 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. Comments:
public Tahereh Heydarian
Abazar West
Isfahan Iran (Islamic Republic of) 8341110005 +98 913 837 0375 taherehdr77@yahoo.com Esfahan University of Medical Sciences scientific Mahbube Valiani
Azadi Square, Hazar Jarib Street, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8199939438 +98 31 3651 4640 valiani@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Couple's desire to get pregnant Primary infertility Normal spermogram Not taking drugs such as clomiphene citrate and letrozole Infertility due to ovulation disorder Absence of structural and anatomical disorders of the uterus such as polyps, myomas, malformations of the Müllerian system, etc. Not suffering from any uncontrolled underlying disease (diabetes, hypertension, lupus, etc.) 18.5-29.9= BMI Failure to use certain drugs (hormonal drugs, drugs related to the underlying disease) during the last three months Non-use of complementary and alternative medicine methods and traditional medicine during the last three months No addiction Absence of any mass, inflammation, or infection in the ears The scores of depression, anxiety, and stress are less than 21, 15, and 26, respectively no limit no limit Female Secondary infertility Abnormal spermogram Taking any medication related to the underlying disease and hormonal treatments during the last 3 months Infertility with causes other than ovulation disorders Suffering from structural and anatomical disorders of the uterus such as polyps, myomas, malformations of the Müllerian system, etc. Having any uncontrolled underlying disease (diabetes, hypertension, lupus, etc.) BMI>30 Application of complementary and alternative medicine methods and traditional medicine during the last three months Presence of any mass, inflammation, or infection in the ears E28.2 Polycystic ovarian syndrome Treatment - Other Placebo Intervention group: In this study, auriculotherapy is used as a non-invasive and side-effect-free treatment method. This approach is based on stimulating specific points on the ear using the "Pointer Plus Excel II" device and placing seeds on these points. The stimulated points include the pituitary, ovary, uterus, pelvis, endocrine, master shoulder, Shen Men, thalamic, relax, and ectoderm points. By stimulating these points, signals are sent to the brain to regulate the body's physiological functions.The auriculotherapy session schedule consists of three menstrual cycles. Starting from the end of menstrual bleeding, each cycle includes four auriculotherapy sessions (every five days), with a total of 12 sessions for each participant. The seeds remain on the ear points for five days and are replaced during the participants' next visit.Participants are advised to press the seeds for one minute every hour throughout the day (except during sleep) to maximize the stimulation effects. Showering while the seeds are on the ears does not interfere with treatment, and reminder calls may be made to encourage participants to press the seeds regularly.After completing the auriculotherapy sessions, assessments (covering clinical, hormonal, and sonographic symptoms of PCOS, as well as depression, stress, and anxiety) are conducted immediately after the intervention and again three months post-intervention. Control group: In the placebo group, points are stimulated falsely without activating the device (and without pressure from the device on the points), and then treated without actual stimulation. Length of menstrual cycle. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: day. Hirsutism. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: Ferriman-Gallwey Score. Acne. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: Global Acne Grading System. Menstrual irregularity. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: Questionnaire (yes-no). E2 hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA (pg/mL). Dehydroepiandrosterone Sulfate hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA (µg/dL). Free Testosterone hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA (pg/mL). Total Testosterone hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA(ng/dl). Follicle Stimulating Hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA(lU/L). Luteinizing Hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA(lU/L). Anti-Müllerian Hormone. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ELISA(ng/ml). Number of follicles. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ultrasound (number). Follicle size. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ultrasound (number (mm)). Ovary volume. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ultrasound(cm³). Endometrial thickness. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: ultrasound(mm). Beta-Human Chorionic Gonadotropin. Timepoint: After completing the intervention. Method of measurement: ELISA( mIU/mL). Stress. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: DAS-21 (Depression Anxiety Stress). Anxiety. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: DAS-21 (Depression Anxiety Stress). Depression. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: DAS-21 (Depression Anxiety Stress). Esfahan University of Medical Sciences Approved 2024-10-16 National Biomedical Research Ethics System Hazarjarib Street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)