PCOS and US Cavitation

NCT05880550 | Completed

• 1 other identifier: US cavitation and PCOS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Infertily related Stress level

  Infertility-Related Stress Scale is a concise, reliable, and validated tool; it facilitates quick screening for infertility's impact on intrapersonal and interpersonal life domains. The IRSS consists of 12 items rated from 1 ("no stress") to 7 ("high stress")., with higher grades means higher stress.

  change from base line at 12 weeks.

• cortisol level

  Saliva samples will be collected with study participants sitting upright in a comfortable position and tilting the head forward, allowing the saliva to pool on the floor of the mouth

  change from base line at 12 weeks.

Secondary Outcomes (2)

• Anthrometric measurement (body mass index and waist-hip ratio)

  change from base line at 12 weeks.

• Hormonal profile

  change from base line at 12 weeks.

Study Arms (2)

study group

EXPERIMENTAL

Other: ultrasound cavitation in addition to aerobic ex

control group

ACTIVE COMPARATOR

Other: aerobic exercises.

Interventions

ultrasound cavitation in addition to aerobic ex 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.

study group

aerobic exercises. OTHER

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

control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Marwa Shafiek Saleh

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Exercise

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: assistance professor doctor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: May 25, 2023
• Primary Completion: August 25, 2023
• Study Completion: September 25, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

EG (1)