Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT06844903
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-25
• Study Start: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-05-26
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum insulin level	12 weeks	Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum insulin levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Insulin Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Serum Luteinizing Hormone (LH) level	12 weeks	Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum LH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The LH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Serum Follicle Stimulating Hormone (FSH) level	12 weeks	Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum FSH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The FSH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Testosterone level	12 weeks	Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum Testosterone levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Testosterone Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.

Secondary Outcome Measures

Name	Time	Method
Number of cysts on ultrasound	12 weeks	It will be measured before intervention and 12 weeks after intervention by ultrasonography.
Diameter of cysts on ultrasound	12 weeks	It will be measured before intervention and 12 weeks after intervention by ultrasonography.
Ovarian volume	12 weeks	It will be measured before intervention and 12 weeks after intervention by ultrasonography.

Trial Locations

Locations (1)

outpatient clinics of Mansoura Hospital; 🇪🇬 Mansoura, Egypt