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NCT06717087Not yet recruiting

Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese PCOS Patients

A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese Polycystic Ovary Syndrome Patients

Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and is characterized by ovulatory dysfunction, increased androgens, and polycystic ovaries. The goal of this randomized control study is to compare the efficacy between acupuncture and metformin both with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rates improvement.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
92 (estimated)
First submitted
24 Nov 2024
Start date
20 Dec 2024
Primary completion date
1 Aug 2025
Lead sponsor
RenJi Hospital
Diseases
Obesity
NCT number
NCT06717087

What you commit to

  • Study type: Interventional
  • Planned participants: 92
  • From 20 Dec 2024 to the primary completion date, 1 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medication within 12 weeks (hormonal drugs, antidepressants, other anti-diabetic drugs, contraceptives, ovulation induction drugs or other drugs that affect the trial in the judgment of the investigator);

Other illness

  • History of severe heart disease, hematologic disease;
  • Any acute disease that has the potential to alter renal function or cause tissue hypoxia;
  • Type I diabetes mellitus;
  • Allergy to metformin hydrochloride or any excipients;
  • No history of acupuncture treatment within 2 months;
  • Persons with disabilities with language impairment or reduced ability to understand the information provided;
  • The man clearly diagnoses infertility-related diseases and factors.

Lab values

  • Known kidney disease (creatinine clearance rate \<45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;

Other

  • Blood pressure \> 160/100 mm Hg;
  • Pregnancy or breastfeeding in the past three months;
  • Alcohol dependence
  • Those who have participated in other clinical studies within three months;

Who the study is looking for

  • Diagnosis of PCOS according to the 2003 Rotterdam criteria with at least two of the following three symptoms: clinical and/or biochemical signs of hyperandrogenism (hirsutism or acne), oligomerism/amenorrhea, and/or polycystic ovaries (PCOS). Biochemical hyperandrogenism is defined as total testosterone \> 2.6 nmol/L or free androgen index \>7. Hirsutism is defined as an FG score ≥7. Oligomenorrhea is defined as menstrual bleeding \> 35 days between menstrual periods in the past year, \< 8 menstrual bleeding. Amenorrhea is \< 3 cycles per year. PCO is defined by transvaginal ultrasound, where one or both ovaries ≥ 12 follicles 2-9 mm and/or ovarian volume ≥ 10 mL. Other endocrine disorders such as atypical congenital adrenal hyperplasia (17-hydroxyprogesterone \<3 nmol/L), androgen-secreting tumors, or suspected Cushing syndrome are excluded.
  • Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old
  • PCOS patients: BMI ≥ 25 to ≤40kg/m2.
  • Willing to sign the consent form.

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.