Response of Menstrual Irregularity and Infertility- Related Stress to Ultrasound Cavitation Combined With Aerobic Exercise in PCOS: Double Blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- cortisol level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
cortisol level
Time Frame: 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
Time Frame: 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 Outcomes
- Hormonal profile(change from base line at 12 weeks.)
- Anthrometric measurement (body mass index and waist-hip ratio)(change from base line at 12 weeks.)
Investigators
Marwa Shafiek Mustafa Saleh
assistance professor doctor
Cairo University