Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome

Kafrelsheikh University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Pulsed ultrasound at acupuncture points; Other: Placebo ultrasound at acupuncture points; Other: Standard care program

Study type: Interventional

Funder types: Other

Identifiers

NCT06844903

KFSIRB200-361

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Pulsed ultrasound at acupuncture points + Standard care program

Experimental group

Description:

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.

Treatment:

Other: Standard care program

Other: Pulsed ultrasound at acupuncture points

Placebo ultrasound + Standard care program

Placebo Comparator group

Description:

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

Treatment:

Other: Standard care program

Other: Placebo ultrasound at acupuncture points