PCOS and US Cavitation

NCT ID: NCT05880550

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2023-09-25

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. Women with this syndrome may have infrequent menstrual periods or amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail to ovulate on a regular basis, with subsequent subfertility in those women that wish to conceive. Recent research stated that interventions aiming to improve QoL among infertile women with PCOS should focus on alleviating infertility-related stress, especially among women with high BMI. So, the purpose of this study is to investigate the effect of ultrasound cavitation combined with aerobic exercise on menstrual irregularity and infertility related stress in women having PCOS.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Study Design

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

Study Groups

study group

Group Type: EXPERIMENTAL

ultrasound cavitation in addition to aerobic ex

Intervention Type: OTHER

Ultrasonic cavitation was turned on, the program of cavitation 40 kHz was chosen, the time was adjusted at 30 minutes. The cavitational head was moved very slowly on each abdominal segment in a small circular movement for 5 minutes. After finishing the focused ultrasound of the 6 segments of the abdomen, the skin was cleaned with cotton.

in addition to that the patients will receive aerobic exercises for 40 minutes.

control group

Group Type: ACTIVE_COMPARATOR

aerobic exercises.

Intervention Type: OTHER

the patients will do aerobic training for 40 minutes on a bicycle ergometer.

Interventions

ultrasound cavitation in addition to aerobic ex

Ultrasonic cavitation was turned on, the program of cavitation 40 kHz was chosen, the time was adjusted at 30 minutes. The cavitational head was moved very slowly on each abdominal segment in a small circular movement for 5 minutes. After finishing the focused ultrasound of the 6 segments of the abdomen, the skin was cleaned with cotton.

in addition to that the patients will receive aerobic exercises for 40 minutes.

Intervention Type: OTHER

aerobic exercises.

the patients will do aerobic training for 40 minutes on a bicycle ergometer.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

All women in this study will be on the following criteria:

• Their ages will range from 20-35 years.
• They will be diagnosed with PCOS by Gynecologist.
• Doesn't receive any treatment for menstrual regularity and fertility during the study.
• BMI above 25kg/m²and less than 35kg/m².
• Waist /hip ratio <.88.

Exclusion Criteria

Women will be excluded if they have one of the following criteria:

• Skin diseases that prevent the application of cavitation.
• Severe cardiovascular disease.
• Other endocrine disordered (hypothyroidism hyperprolactinemia).
• Patients that who take hormonal treatment within the last 3 months before the study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Shafiek Mustafa Saleh

assistance professor doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marwa Shafiek Saleh

Giza, , Egypt

Countries

Egypt

Other Identifiers

US cavitation and PCOS

Identifier Type: -

Identifier Source: org_study_id