Polycystic Ovary SyndromeNCT05039125
Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
A study testing ultrasonic cavitation in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Thirty women diagnosed with PCOS had participated in the study. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages were from 20-35 years. Their BMI was from 30 - 35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- ultrasonic cavitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2018to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulligravida women with PCOS complaining of at least one year of infertility. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages ranged from 20-35 years. Their BMI ranged from 30-35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were from the same social class.
Who cannot join
- history of heart disease, high cholesterol, l iver or kidney diseases, diabetes mellitus, hypertension, pregnancy, scarring, hernias, or skin diseases in the abdominal region that prevent the application of ultrasound cavitation
Trial locations and contacts
1 site in 1 country.
About this study
Thirty women diagnosed with PCOS had participated in the study. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages were from 20-35 years. Their BMI was from 30 - 35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were recruited randomly from the outpatient clinic of gynecology in Minya governorate hospital. They were randomly assigned into two groups equal in number: (A and B); group A (n=15) received 40000HZ ultrasound cavitation, group B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician.
Read the detailed description
Participants in both groups were told to follow a low calorie diet (1200 Kcal/day) tailored to their specific needs (low in fat (15%), high in complex carbs (55%), and adequate in protein) (30 percent ) (11).
The application procedure of ultrasound cavitation for both groups (A and B):-
- Each participant in both groups (A and B) received instructions on the treatment techniques as well as the benefits of the USFC.
- To improve lymphatic drainage, each subject was encouraged to consume one liter of water before and after the therapy sessions.
- Each participant was urged to empty her bladder before beginning each treatment session so order to remain comfortable and relaxed throughout the session.
- From a standing position, each participant's abdomen was divided transversally into three sections; see fig (1) 1- Part I: from the xiphoid process to 3cm above the umbilicus, 2- Section II: from 2cm below the umbilicus to the pubic bone, and vertically to the linea alba, each part was separated into right and left segments, resulting in a total of 6 abdominal segments.
- Part III: 3cm above the umbilicus to 2cm below the umbilicus
- After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head.
- The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased.
- The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes.
- After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton.
For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months.
For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- ultrasonic cavitation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic cavitationRadiation
- From a standing position, each participant's abdomen was divided transversally into three sections; resulting in a total of 6 abdominal segments.
- Part III: 3cm above the umbilicus to 2cm below the umbilicus
- After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head.
- The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased.
- The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes.
- After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton.
For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months.
For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 40000HZ ultrasound cavitation | Active comparator | group A (n=15) received 40000HZ ultrasound cavitation, Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician. Receives: Radiation: ultrasonic cavitation |
| 2600HZ ultrasound cavitation | Active comparator | group B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician. Receives: Radiation: ultrasonic cavitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measures
Weight-Height scale was used for each participant of the two studied groups (A \& B) before and after the study to measure the weight and height
Measured: 2 moths after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start30 Apr 2018
- Primary completion11 Jan 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Mohamed Maged M ElGoly, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039125
- Sponsor's protocol ID
- 62
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT05039125
- Acronym / sponsor ID
- 62
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty women diagnosed with PCOS had participated in the study. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages were from 20-35 years. Their BMI was from 30 - 35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were recruited randomly from the outpatient clinic of gynecology in Minya governorate hospital. They were randomly assigned into two groups equal in number: (A and B); group A (n=15) received 40000HZ ultrasound cavitation, group B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician.
Detailed description
Participants in both groups were told to follow a low calorie diet (1200 Kcal/day) tailored to their specific needs (low in fat (15%), high in complex carbs (55%), and adequate in protein) (30 percent ) (11).
The application procedure of ultrasound cavitation for both groups (A and B):-
- Each participant in both groups (A and B) received instructions on the treatment techniques as well as the benefits of the USFC.
- To improve lymphatic drainage, each subject was encouraged to consume one liter of water before and after the therapy sessions.
- Each participant was urged to empty her bladder before beginning each treatment session so order to remain comfortable and relaxed throughout the session.
- From a standing position, each participant's abdomen was divided transversally into three sections; see fig (1) 1- Part I: from the xiphoid process to 3cm above the umbilicus, 2- Section II: from 2cm below the umbilicus to the pubic bone, and vertically to the linea alba, each part was separated into right and left segments, resulting in a total of 6 abdominal segments.
- Part III: 3cm above the umbilicus to 2cm below the umbilicus
- After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head.
- The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased.
- The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes.
- After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton.
For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months.
For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40000HZ ultrasound cavitation | Active comparator | Radiation: ultrasonic cavitationgroup A (n=15) received 40000HZ ultrasound cavitation, Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician. |
| 2600HZ ultrasound cavitation | Active comparator | Radiation: ultrasonic cavitationgroup B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- nulligravida women with PCOS complaining of at least one year of infertility. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages ranged from 20-35 years. Their BMI ranged from 30-35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were from the same social class.
Key exclusion criteria (1 listed)
- history of heart disease, high cholesterol, l iver or kidney diseases, diabetes mellitus, hypertension, pregnancy, scarring, hernias, or skin diseases in the abdominal region that prevent the application of ultrasound cavitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonic cavitation* From a standing position, each participant's abdomen was divided transversally into three sections; resulting in a total of 6 abdominal segments. * Part III: 3cm above the umbilicus to 2cm below the umbilicus * After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head. * The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased. * The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes. * After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton. For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months. For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months | Radiation | 2600HZ ultrasound cavitation, 40000HZ ultrasound cavitation |
Primary outcome
Anthropometric measures
Time frame: 2 moths after treatment
Weight-Height scale was used for each participant of the two studied groups (A \& B) before and after the study to measure the weight and height
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mohamed Maged M ElGoly principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic cavitation in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measures (time frame: 2 moths after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.