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Clinical Trials/NCT05880550
NCT05880550
Completed
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentMay 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
cortisol level
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2023
End Date
September 25, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Shafiek Mustafa Saleh

assistance professor doctor

Cairo University

Eligibility Criteria

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.)

Study Sites (1)

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