Polycystic Ovary SyndromeNCT06844903
Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome
A study testing Pulsed ultrasound at acupuncture points in people with Polycystic Ovary Syndrome, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (PCOS) patient. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Pulsed ultrasound at acupuncture points
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2025to 30 Jun 2025
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adults range between 18 and 35 years.
- All patients will be stopped drugs that affect the result during study period.
- body mass index (BMI) not exceeding 30 kg/m2.
- have the symptoms of oligomenorrhea or amenorrhea (appendix I).
- No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis).
- Not having any type of cancer.
Who cannot join
- Any malignancy
- Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
- Participants who refuse to stop the drugs that affect the study during study period.
- Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet, metal or plastic implantation.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (PCOS) patient.
Read the detailed description
PCOS is a life-long condition and although the exact cause is yet to be identified, it is believed to have epigenetic origins. It is the main gynecological endocrinopathy of reproductive age. It is the most common cause of infertility due to anovulation. In many countries, it represents the leading cause of female infertility.
Signs and symptoms are mediated by hormonal disorder including elevated androgens and fasting insulin, and abnormal relative ratio of the gonadotropins luteinizing hormone (LH) and follicle stimulating hormone (FSH). Endocrine imbalances occur within the framework of disordered ovarian folliculogenesis, chronic anovulation, clinical signs of hyperandrogenism and metabolic syndrome.
The standard treatment of PCOS includes oral medications, lifestyle changes, and surgery. Pharmacology-based treatments are effective in only 60% of patients. Therefore, acupuncture provides an alternative.
Acupuncture therapy in female with PCOS and ovulatory disorder has been known to bring enduring useful results on the endocrine system and menstrual cycle, without complications.
In women with PCOS and IR, acupuncture was superior to metformin in improving glucose metabolism and had a lower incidence of gastrointestinal adverse effects.
There were no studies using ultrasound acupoint to improve symptoms of PCOS patients, so this study will discuss this method to describe its effect on PCOS patients.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Pulsed ultrasound at acupuncture points, Placebo ultrasound at acupuncture points, Standard care program
- 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.
Pulsed ultrasound at acupuncture pointsOther
The experimental group will receive pulsed ultrasound at bilateral acupuncture points of St29, Sp6 and unilateral acupuncture points on Ren4 and Ren5 in addition to standard care program for 12 weeks.
Placebo ultrasound at acupuncture pointsOther
The placebo group will receive the same but in Placebo manner for 12 weeks.
Standard care programOther
All participants in both groups will be given an info brochure, that included advice on a healthy diet as a low-carbohydrate and high-protein diet, high dietary fiber, and less saturated fat in addition to engagement in aerobic exercise, fast walking for at least 30 - 45 min, 3 days a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed ultrasound at acupuncture points + Standard care program | Experimental | It will consist of 22 patients, who will receive pulsed therapeutic ultrasound (1 MHz) at bilateral acupuncture points of St29, Sp6,and unilateral acupuncture points of Ren4, Ren5, in addition to standard care program. Receives: Other: Pulsed ultrasound at acupuncture points; Other: Standard care program |
| Placebo ultrasound + Standard care program | Placebo comparator | It will consist of 22 patients, who will receive placebo therapeutic ultrasound in addition to standard care program. Receives: Other: Placebo ultrasound at acupuncture points; Other: Standard care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum insulin level
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum insulin levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Insulin Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Measured: 12 weeks
Serum Luteinizing Hormone (LH) level
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum LH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The LH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Measured: 12 weeks
Serum Follicle Stimulating Hormone (FSH) level
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum FSH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The FSH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Measured: 12 weeks
Testosterone level
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum Testosterone levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Testosterone Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Measured: 12 weeks
Secondary outcomes (3)
Number of cysts on ultrasound
It will be measured before intervention and 12 weeks after intervention by ultrasonography.
Measured: 12 weeks
Diameter of cysts on ultrasound
It will be measured before intervention and 12 weeks after intervention by ultrasonography.
Measured: 12 weeks
Ovarian volume
It will be measured before intervention and 12 weeks after intervention by ultrasonography.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start26 Feb 2025
- Primary completion26 Jun 2025
- Study completion30 Jun 2025
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 Kafrelsheikh 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Fathy Elsayed Atwa Elsharabasy, Kafrelsheikh University
- Investigators
- Fayiz Farouk El Shamy, PhD, Study chair, Professor, Kafrelsheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844903
- Sponsor's protocol ID
- KFSIRB200-361
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06844903
- Acronym / sponsor ID
- KFSIRB200-361
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Feb 2025 (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.
This study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (PCOS) patient.
Detailed description
PCOS is a life-long condition and although the exact cause is yet to be identified, it is believed to have epigenetic origins. It is the main gynecological endocrinopathy of reproductive age. It is the most common cause of infertility due to anovulation. In many countries, it represents the leading cause of female infertility.
Signs and symptoms are mediated by hormonal disorder including elevated androgens and fasting insulin, and abnormal relative ratio of the gonadotropins luteinizing hormone (LH) and follicle stimulating hormone (FSH). Endocrine imbalances occur within the framework of disordered ovarian folliculogenesis, chronic anovulation, clinical signs of hyperandrogenism and metabolic syndrome.
The standard treatment of PCOS includes oral medications, lifestyle changes, and surgery. Pharmacology-based treatments are effective in only 60% of patients. Therefore, acupuncture provides an alternative.
Acupuncture therapy in female with PCOS and ovulatory disorder has been known to bring enduring useful results on the endocrine system and menstrual cycle, without complications.
In women with PCOS and IR, acupuncture was superior to metformin in improving glucose metabolism and had a lower incidence of gastrointestinal adverse effects.
There were no studies using ultrasound acupoint to improve symptoms of PCOS patients, so this study will discuss this method to describe its effect on PCOS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed ultrasound at acupuncture points + Standard care program | Experimental | Other: Pulsed ultrasound at acupuncture points, Other: Standard care programIt will consist of 22 patients, who will receive pulsed therapeutic ultrasound (1 MHz) at bilateral acupuncture points of St29, Sp6,and unilateral acupuncture points of Ren4, Ren5, in addition to standard care program. |
| Placebo ultrasound + Standard care program | Placebo comparator | Other: Placebo ultrasound at acupuncture points, Other: Standard care programIt will consist of 22 patients, who will receive placebo therapeutic ultrasound in addition to standard care program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults range between 18 and 35 years.
- All patients will be stopped drugs that affect the result during study period.
- body mass index (BMI) not exceeding 30 kg/m2.
- have the symptoms of oligomenorrhea or amenorrhea (appendix I).
- No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis).
Key exclusion criteria (4 listed)
- Any malignancy
- Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
- Participants who refuse to stop the drugs that affect the study during study period.
- Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet, metal or plastic implantation.
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 |
|---|---|---|
| Pulsed ultrasound at acupuncture pointsThe experimental group will receive pulsed ultrasound at bilateral acupuncture points of St29, Sp6 and unilateral acupuncture points on Ren4 and Ren5 in addition to standard care program for 12 weeks. | Other | Pulsed ultrasound at acupuncture points + Standard care program |
| Placebo ultrasound at acupuncture pointsThe placebo group will receive the same but in Placebo manner for 12 weeks. | Other | Placebo ultrasound + Standard care program |
| Standard care programAll participants in both groups will be given an info brochure, that included advice on a healthy diet as a low-carbohydrate and high-protein diet, high dietary fiber, and less saturated fat in addition to engagement in aerobic exercise, fast walking for at least 30 - 45 min, 3 days a week for 12 weeks. | Other | Placebo ultrasound + Standard care program, Pulsed ultrasound at acupuncture points + Standard care program |
Primary outcome
Serum insulin level
Time frame: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum insulin levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Insulin Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Serum Luteinizing Hormone (LH) level
Time frame: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum LH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The LH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Serum Follicle Stimulating Hormone (FSH) level
Time frame: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum FSH levels. Centrifugation will perform at 4600 rpm for 15 minutes. The FSH Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
Testosterone level
Time frame: 12 weeks
Blood samples will be obtained before intervention and 12 weeks after intervention by venepuncture for 20 seconds and transfer to the laboratory in gel tubes for measurement of serum Testosterone levels. Centrifugation will perform at 4600 rpm for 15 minutes. The Testosterone Quantitative Tests are based on a solid phase enzyme-linked immunosorbent assay (ELISA). Sampling time of insulin will be an 8 -hour fasting specimen.
3 secondary outcomes
Number of cysts on ultrasound
Time frame: 12 weeks
Diameter of cysts on ultrasound
Time frame: 12 weeks
Ovarian volume
Time frame: 12 weeks
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 3 Jul 2025.
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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.
Fayiz Farouk El Shamy, PhD study chair
Professor, Kafrelsheikh 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 Pulsed ultrasound at acupuncture points in people with Polycystic Ovary Syndrome, run by Kafrelsheikh 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 6 inclusion and 4 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 3 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
Serum insulin level (time frame: 12 weeks). The study lists 4 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 3 Jul 2025.