PCOS and US Cavitation

Response of Menstrual Irregularity and Infertility- Related Stress to Ultrasound Cavitation Combined With Aerobic Exercise in PCOS: Double Blinded Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Intervention / Treatment: Other: ultrasound cavitation in addition to aerobic ex; Other: aerobic exercises.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marwa S saleh; Phone Number: 01008342466; Email: marwa_shafiek2000@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Other: aerobic exercises.; the patients will do aerobic training for 40 minutes on a bicycle ergometer.
Experimental: study group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infertily related Stress level	fertility problem inventory scale will be used for assessing the stress level pre and post treatment.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthrometric measurement (BMI And waist hip ratio)	BMI and waist/hip ratio Measurements of BMI in which the weight in kilograms divided by the square of the heights in meters and waist to hip circumference measured with a soft tape at the level of the umbilicus and the anterior superior iliac spine with woman in the standing position, were made before treatment and after the end of the study period	change from base line at 12 weeks.
Hormonal profile (LH- FSH - LH /FSH ratio).	Blood samples will be drown from an antecubital vein of each patient in the study on two occasions, firstly at the end at 2 nd or 3 rd day of the menstrual cycle after an overnight fasting just before starting her treatment regimen and secondly after 3 months of the treatment. It will be centrifuged within 2 hours after withdrawal. Serum will be stared at -20OC and assayed for LH and FSH with chemiluminescent enzyme immunoassay kits. Assays for fasting insulin by RIA kits and SHBG will be determined by using an immunoradiometric assay (IRMA).	change from base line at 12 weeks.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2023
• Primary Completion (Estimated): August 25, 2023
• Study Completion (Estimated): September 25, 2023

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome
• Other Study ID Numbers: US cavitation and PCOS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No