Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome

NCT06844903 | Completed

• 1 other identifier: KFSIRB200-361
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

• Serum insulin level

  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.

  12 weeks

• Serum Luteinizing Hormone (LH) level

  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.

  12 weeks

• Serum Follicle Stimulating Hormone (FSH) level

  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.

  12 weeks

• Testosterone level

  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.

  12 weeks

Secondary Outcomes (3)

• Number of cysts on ultrasound

  12 weeks

• Diameter of cysts on ultrasound

  12 weeks

• Ovarian volume

  12 weeks

Study Arms (2)

Pulsed ultrasound at acupuncture points + Standard care program

EXPERIMENTAL

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.

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

Placebo ultrasound + Standard care program

PLACEBO COMPARATOR

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

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

Interventions

Pulsed ultrasound at acupuncture points 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.

Pulsed ultrasound at acupuncture points + Standard care program

Placebo ultrasound at acupuncture points OTHER

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

Placebo ultrasound + Standard care program

Standard care program 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; Pulsed ultrasound at acupuncture points + Standard care program

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

outpatient clinics of Mansoura Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Fayiz Farouk El Shamy, PhD

  Professor, Kafrelsheikh university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: February 26, 2025
• Primary Completion: June 26, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

EG (1)