PCOS and US Cavitation

Not Applicable

Completed

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Interventions: Other: ultrasound cavitation in addition to aerobic ex; Other: aerobic exercises.

• Registration Number: NCT05880550
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study Start: 2023-05-25
• Study First Posted: 2023-05-30
• Primary Completion: 2023-08-25
• Study Completion: 2023-09-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	ultrasound cavitation in addition to aerobic ex	-
control group	aerobic exercises.	-

Primary Outcome Measures

Name	Time	Method
cortisol level	change from base line at 12 weeks.	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
Infertily related Stress level	change from base line at 12 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Hormonal profile	change from base line at 12 weeks.	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).
Anthrometric measurement (body mass index and waist-hip ratio)	change from base line at 12 weeks.	BMI and waist/hip ratio Measurements of body mass index 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

Trial Locations

Locations (1)

Marwa Shafiek Saleh; 🇪🇬 Giza, Egypt