Polycystic Ovary SyndromeNCT04875312
Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs
A study testing Ultrasound cavitation in group A and Electro acupuncture in group B in people with Polycystic Ovary Syndrome, run by Mohamed Abdel Hamid elgaedy.
Trial summary
The aim of this study is to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome …………………………………………………………………… BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder that… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Ultrasound cavitation in group A and Electro acupuncture in group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2021to 1 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages will be ranged between 20-35 year old.
- Their body mass index will be ranged from 30-40 kg/m2.
- All of them are married women.
Who cannot join
- Women will be excluded if they have one of the following criteria:
- Diabetes mellitus.
- Thyroid dysfunction.
- Concomitant cardiovascular disorders.
- Respiratory, renal and liver dysfunction.
- Tubal adhesions as well as uterine abnormalities.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome
The aim of this study is to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome …………………………………………………………………… BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder that occurs in 6 - 10% of women at the reproductive age. It is associated with an-ovulation, infertility, hyperandrogenism, obesity and insulin resistance.
Endocrine characteristics of PCOS are elevated serum concentrations of androgens and Luteinizing hormone (LH) and decreased concentrations of sex hormone binding globulin (SHBG).
Read more
Ultrasound cavitation is the method in handling Subcutaneous Adipose Tissue (, especially in destroying subcutaneous fat and shaping a particular part of the body. As one of the non-surgical correction method, UC is preferred for lowering the risk of complications due to obesity.
UC reported a greater decrease of the WHR, suggesting a valuable modification of fat distribution pattern, especially at the abdominal level. It improves rates of ovulation, provides higher incidence of regular menstrual cycles and lower levels of total testosterone.
Acupuncture is a treatment method used in Traditional Chinese Medicine. Electroacupuncture promotes follicle development and corrects reproductive endocrine dysfunction in ovaries by regulating the functions of the hypothalamus, pituitary and ovaries
Read the detailed description
This study will be designed as prospective, randomized, single blind, experimental, pre-post test , controlled- trial study.
Simple Size Calculation:
I- Subjects:
Forty obese infertile patients with poly cystic ovarian syndrome will participate in this study to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones. They will be selected randomly from Out Patient Clinic of Aga Hospital Central, in Aga. All patients will be divided randomly into two equal groups (A\&B).
Group A:
twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)
Group B:
twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day) II- Instrumentations:
- Recording data sheet (Appendix II).
- Standard weight height scale: measure BMI
- Tape measurement: measure waist/hip ratio.
- Test tubes: used to collect the blood samples from obese infertile patients
- Kites: used for assessment of serum progesterone level, testosterone, LH and FSH.
- Abdominal ultrasongraphy: measure ovulation rate.
- cavitation in group A 8- electroacupuncture in group B
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Ultrasound cavitation in group A, Electro acupuncture in group B
- 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.
Ultrasound cavitation in group ADevice
Group A:
twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)
Electro acupuncture in group BDevice
Group B:
twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)
| Study group | Role | What they receive |
|---|---|---|
| Group USC | Experimental | Effect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome Receives: Device: Ultrasound cavitation in group A |
| Group EA | Experimental | Effect of electro acupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome Receives: Device: Electro acupuncture in group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.
Measured: up to 12 weeks
waist/hip ratio:
It will be use tape measurement to calculate the waist/hip ratio.
Measured: up to 12 weeks
Testosterone hormones :
They will be use kites for assessment of level of testosterone hormones
Measured: up to 12 weeks
FSH Hormone
They will be use kites for assessment of level of FSH hormones
Measured: up to 12 weeks
Lh hormones
They will be use kites for assessment of level of LH hormones
Measured: up to 12 weeks
Progesterone hormones
They will be use kites for assessment of level of progesterone hormones
Measured: up to 12 weeks
Height
It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.
Measured: up to 12 weeks
Secondary outcomes (1)
Ovulation rate
It will be use ultrasonography for measuring ovulation rate.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start30 Apr 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Abdel Hamid elgaedy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Abdel Hamid elgaedy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875312
- Sponsor's protocol ID
- 012/003187
- Status last verified
- May 2021
- First submitted
- 19 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT04875312
- Acronym / sponsor ID
- 012/003187
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mohamed Abdel Hamid elgaedyUniversity, hospital or other
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 6 May 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.
The aim of this study is to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome …………………………………………………………………… BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder that occurs in 6 - 10% of women at the reproductive age. It is associated with an-ovulation, infertility, hyperandrogenism, obesity and insulin resistance.
Endocrine characteristics of PCOS are elevated serum concentrations of androgens and Luteinizing hormone (LH) and decreased concentrations of sex hormone binding globulin (SHBG).
Ultrasound cavitation is the method in handling Subcutaneous Adipose Tissue (, especially in destroying subcutaneous fat and shaping a particular part of the body. As one of the non-surgical correction method, UC is preferred for lowering the risk of complications due to obesity.
UC reported a greater decrease of the WHR, suggesting a valuable modification of fat distribution pattern, especially at the abdominal level. It improves rates of ovulation, provides higher incidence of regular menstrual cycles and lower levels of total testosterone.
Acupuncture is a treatment method used in Traditional Chinese Medicine. Electroacupuncture promotes follicle development and corrects reproductive endocrine dysfunction in ovaries by regulating the functions of the hypothalamus, pituitary and ovaries
Detailed description
This study will be designed as prospective, randomized, single blind, experimental, pre-post test , controlled- trial study.
Simple Size Calculation:
I- Subjects:
Forty obese infertile patients with poly cystic ovarian syndrome will participate in this study to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones. They will be selected randomly from Out Patient Clinic of Aga Hospital Central, in Aga. All patients will be divided randomly into two equal groups (A\&B).
Group A:
twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)
Group B:
twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day) II- Instrumentations:
- Recording data sheet (Appendix II).
- Standard weight height scale: measure BMI
- Tape measurement: measure waist/hip ratio.
- Test tubes: used to collect the blood samples from obese infertile patients
- Kites: used for assessment of serum progesterone level, testosterone, LH and FSH.
- Abdominal ultrasongraphy: measure ovulation rate.
- cavitation in group A 8- electroacupuncture in group B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group USC | Experimental | Device: Ultrasound cavitation in group AEffect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome |
| Group EA | Experimental | Device: Electro acupuncture in group BEffect of electro acupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Their ages will be ranged between 20-35 year old.
- Their body mass index will be ranged from 30-40 kg/m2.
- All of them are married women.
Key exclusion criteria (6 listed)
- Women will be excluded if they have one of the following criteria:
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 |
|---|---|---|
| Ultrasound cavitation in group AGroup A: twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day) | Device | Group USC |
| Electro acupuncture in group BGroup B: twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day) | Device | Group EA |
Primary outcome
weight
Time frame: up to 12 weeks
It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.
waist/hip ratio:
Time frame: up to 12 weeks
It will be use tape measurement to calculate the waist/hip ratio.
Testosterone hormones :
Time frame: up to 12 weeks
They will be use kites for assessment of level of testosterone hormones
FSH Hormone
Time frame: up to 12 weeks
They will be use kites for assessment of level of FSH hormones
Lh hormones
Time frame: up to 12 weeks
They will be use kites for assessment of level of LH hormones
Progesterone hormones
Time frame: up to 12 weeks
They will be use kites for assessment of level of progesterone hormones
Height
Time frame: up to 12 weeks
It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.
1 secondary outcome
Ovulation rate
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound cavitation in group A and Electro acupuncture in group B in people with Polycystic Ovary Syndrome, run by Mohamed Abdel Hamid elgaedy.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MANAL Ahmed El Shafei Mohamed, Lecturer (201220664518, Manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: up to 12 weeks). The study lists 7 primary outcomes in all. 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 7 May 2021.