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

NCT04875312 | Unknown

• 1 other identifier: 012/003187
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (7)

• weight

  It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.

  up to 12 weeks

• waist/hip ratio:

  It will be use tape measurement to calculate the waist/hip ratio.

  up to 12 weeks

• Testosterone hormones :

  They will be use kites for assessment of level of testosterone hormones

  up to 12 weeks

• FSH Hormone

  They will be use kites for assessment of level of FSH hormones

  up to 12 weeks

• Lh hormones

  They will be use kites for assessment of level of LH hormones

  up to 12 weeks

• Progesterone hormones

  They will be use kites for assessment of level of progesterone hormones

  up to 12 weeks

• Height

  It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.

  up to 12 weeks

Secondary Outcomes (1)

• Ovulation rate

  up to 12 weeks

Study Arms (2)

Group USC

EXPERIMENTAL

Effect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome

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

Device: Electro acupuncture in group B

Interventions

Ultrasound cavitation in group A DEVICE

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 USC

Electro acupuncture in group B DEVICE

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)

Group EA

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Abdel Hamid elgaedy: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

MANAL Ahmed El Shafei Mohamed, Lecturer

CONTACT

201220664518; Manalpt1989@gmail.com

Mohamed Abdel Hamid El gaedy, Master

CONTACT

+20 109 943 0782; dr.mohamed_elgaedy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head OF physical therapy in AGA hospital

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 6, 2021
• Study Start: April 30, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From may 2021 to may 2022