Polycystic Ovary Syndrome
Conditions
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.
Interventions
OTHERPulsed ultrasound at acupuncture points
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.
OTHERPlacebo ultrasound at acupuncture points
The placebo group will receive the same but in Placebo manner for 12 weeks.
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.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum insulin level | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diameter of cysts on ultrasound | 12 weeks | It will be measured before intervention and 12 weeks after intervention by ultrasonography. |
| Ovarian volume | 12 weeks | It will be measured before intervention and 12 weeks after intervention by ultrasonography. |
| Number of cysts on ultrasound | 12 weeks | It will be measured before intervention and 12 weeks after intervention by ultrasonography. |
Countries
Egypt
Outcome results
None listed