Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome

NCT ID: NCT06844903

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-26
• Study Completion Date: 2025-06-30

Brief Summary

This study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (PCOS) patient.

Detailed Description

PCOS is a life-long condition and although the exact cause is yet to be identified, it is believed to have epigenetic origins. It is the main gynecological endocrinopathy of reproductive age. It is the most common cause of infertility due to anovulation. In many countries, it represents the leading cause of female infertility.

Signs and symptoms are mediated by hormonal disorder including elevated androgens and fasting insulin, and abnormal relative ratio of the gonadotropins luteinizing hormone (LH) and follicle stimulating hormone (FSH). Endocrine imbalances occur within the framework of disordered ovarian folliculogenesis, chronic anovulation, clinical signs of hyperandrogenism and metabolic syndrome.

The standard treatment of PCOS includes oral medications, lifestyle changes, and surgery. Pharmacology-based treatments are effective in only 60% of patients. Therefore, acupuncture provides an alternative.

Acupuncture therapy in female with PCOS and ovulatory disorder has been known to bring enduring useful results on the endocrine system and menstrual cycle, without complications.

In women with PCOS and IR, acupuncture was superior to metformin in improving glucose metabolism and had a lower incidence of gastrointestinal adverse effects.

There were no studies using ultrasound acupoint to improve symptoms of PCOS patients, so this study will discuss this method to describe its effect on PCOS patients.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulsed ultrasound at acupuncture points + Standard care program

It will consist of 22 patients, who will receive pulsed therapeutic ultrasound (1 MHz) at bilateral acupuncture points of St29, Sp6,and unilateral acupuncture points of Ren4, Ren5, in addition to standard care program.

Group Type: EXPERIMENTAL

Pulsed ultrasound at acupuncture points

Intervention Type: OTHER

The experimental group will receive pulsed ultrasound at bilateral acupuncture points of St29, Sp6 and unilateral acupuncture points on Ren4 and Ren5 in addition to standard care program for 12 weeks.

Standard care program

Intervention Type: OTHER

All participants in both groups will be given an info brochure, that included advice on a healthy diet as a low-carbohydrate and high-protein diet, high dietary fiber, and less saturated fat in addition to engagement in aerobic exercise, fast walking for at least 30 - 45 min, 3 days a week for 12 weeks.

Placebo ultrasound + Standard care program

It will consist of 22 patients, who will receive placebo therapeutic ultrasound in addition to standard care program.

Group Type: PLACEBO_COMPARATOR

Placebo ultrasound at acupuncture points

Intervention Type: OTHER

The placebo group will receive the same but in Placebo manner for 12 weeks.

Standard care program

Intervention Type: OTHER

All participants in both groups will be given an info brochure, that included advice on a healthy diet as a low-carbohydrate and high-protein diet, high dietary fiber, and less saturated fat in addition to engagement in aerobic exercise, fast walking for at least 30 - 45 min, 3 days a week for 12 weeks.

Interventions

Pulsed ultrasound at acupuncture points

The experimental group will receive pulsed ultrasound at bilateral acupuncture points of St29, Sp6 and unilateral acupuncture points on Ren4 and Ren5 in addition to standard care program for 12 weeks.

Intervention Type: OTHER

Placebo ultrasound at acupuncture points

The placebo group will receive the same but in Placebo manner for 12 weeks.

Intervention Type: OTHER

Standard care program

All participants in both groups will be given an info brochure, that included advice on a healthy diet as a low-carbohydrate and high-protein diet, high dietary fiber, and less saturated fat in addition to engagement in aerobic exercise, fast walking for at least 30 - 45 min, 3 days a week for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults range between 18 and 35 years.
• All patients will be stopped drugs that affect the result during study period.
• body mass index (BMI) not exceeding 30 kg/m2.
• have the symptoms of oligomenorrhea or amenorrhea (appendix I).
• No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis).
• Not having any type of cancer.

Exclusion Criteria

• Any malignancy
• Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
• Participants who refuse to stop the drugs that affect the study during study period.
• Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet, metal or plastic implantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Ola Fathy Elsayed Atwa Elsharabasy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fayiz Farouk El Shamy, PhD

Role: STUDY_CHAIR

Professor, Kafrelsheikh university

Locations

outpatient clinics of Mansoura Hospital

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-361

Identifier Type: -

Identifier Source: org_study_id