Clinical trial NCT06844903: Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome
Official title: Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum insulin level
timeFrame: 12 weeks
measure: Serum Luteinizing Hormone (LH) level
timeFrame: 12 weeks
measure: Serum Follicle Stimulating Hormone (FSH) level
timeFrame: 12 weeks
measure: Testosterone level
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of cysts on ultrasound
timeFrame: 12 weeks
measure: Diameter of cysts on ultrasound
timeFrame: 12 weeks
measure: Ovarian volume
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: outpatient clinics of Mansoura Hospital
Study officials:
affiliation: Professor, Kafrelsheikh university
name: Fayiz Farouk El Shamy, PhD
role: STUDY_CHAIR
References: