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Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs

Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04875312
Enrollment
40
Registered
2021-05-06
Start date
2021-04-30
Completion date
2021-08-01
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Brief 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 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: 1. Recording data sheet (Appendix II). 2. Standard weight height scale: measure BMI 3. Tape measurement: measure waist/hip ratio. 4. Test tubes: used to collect the blood samples from obese infertile patients 5. Kites: used for assessment of serum progesterone level, testosterone, LH and FSH. 6. Abdominal ultrasongraphy: measure ovulation rate. 7. cavitation in group A 8- electroacupuncture in group B

Interventions

DEVICEUltrasound cavitation in group A

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)

DEVICEElectro acupuncture in group B

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)

Sponsors

Mohamed Abdel Hamid elgaedy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

1. Their ages will be ranged between 20-35 year old. 2. Their body mass index will be ranged from 30-40 kg/m2. 3. All of them are married women.

Exclusion criteria

* Women will be excluded if they have one of the following criteria: 1. Diabetes mellitus. 2. Thyroid dysfunction. 3. Concomitant cardiovascular disorders. 4. Respiratory, renal and liver dysfunction. 5. Tubal adhesions as well as uterine abnormalities.

Design outcomes

Primary

MeasureTime frameDescription
Heightup to 12 weeksIt will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.
weightup to 12 weeksIt will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.
waist/hip ratio:up to 12 weeksIt will be use tape measurement to calculate the waist/hip ratio.
Testosterone hormones :up to 12 weeksThey will be use kites for assessment of level of testosterone hormones
FSH Hormoneup to 12 weeksThey will be use kites for assessment of level of FSH hormones
Lh hormonesup to 12 weeksThey will be use kites for assessment of level of LH hormones
Progesterone hormonesup to 12 weeksThey will be use kites for assessment of level of progesterone hormones

Secondary

MeasureTime frameDescription
Ovulation rateup to 12 weeksIt will be use ultrasonography for measuring ovulation rate.

Contacts

Primary ContactMANAL Ahmed El Shafei Mohamed, Lecturer
Manalpt1989@gmail.com201220664518
Backup ContactMohamed Abdel Hamid El gaedy, Master
dr.mohamed_elgaedy@yahoo.com+20 109 943 0782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026