Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome

NCT05039125 | Completed DMC

• 1 other identifier: 62
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty women diagnosed with PCOS had participated in the study. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages were from 20-35 years. Their BMI was from 30 - 35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were recruited randomly from the outpatient clinic of gynecology in Minya governorate hospital. They were randomly assigned into two groups equal in number: (A and B); group A (n=15) received 40000HZ ultrasound cavitation, group B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Anthropometric measures

  Weight-Height scale was used for each participant of the two studied groups (A \& B) before and after the study to measure the weight and height

  2 moths after treatment

Study Arms (2)

40000HZ ultrasound cavitation

ACTIVE COMPARATOR

group A (n=15) received 40000HZ ultrasound cavitation, Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician.

Radiation: ultrasonic cavitation

2600HZ ultrasound cavitation

ACTIVE COMPARATOR

group B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician.

Radiation: ultrasonic cavitation

Interventions

ultrasonic cavitation RADIATION

* From a standing position, each participant's abdomen was divided transversally into three sections; resulting in a total of 6 abdominal segments. * Part III: 3cm above the umbilicus to 2cm below the umbilicus * After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head. * The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased. * The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes. * After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton. For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months. For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months

2600HZ ultrasound cavitation; 40000HZ ultrasound cavitation

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• nulligravida women with PCOS complaining of at least one year of infertility. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages ranged from 20-35 years. Their BMI ranged from 30-35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were from the same social class.

You may not qualify if:

• history of heart disease, high cholesterol, l iver or kidney diseases, diabetes mellitus, hypertension, pregnancy, scarring, hernias, or skin diseases in the abdominal region that prevent the application of ultrasound cavitation

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, 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

• Ahmed Mohamed Maged M ElGoly

  Cairo University

  PRINCIPAL INVESTIGATOR

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: professor

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: April 30, 2018
• Primary Completion: January 11, 2021
• Study Completion: August 2, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)