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Efficacy and mechanism of bariatric surgery compared with drug therapy in obese women with polycystic ovary syndrome

Efficacy and mechanism of bariatric surgery compared with drug therapy in obese women with polycystic ovary syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055291
Enrollment
Unknown
Registered
2022-01-05
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-01-23

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

Conditions

obesity with polycystic ovary syndrome (PCOS)

Interventions

Obesity PCOS Surgery Group:bariatric surgery
Obesity Non-PCOS Surgery Group:bariatric surgery
Obesity PCOS Drug Group:drug

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for PCOS patients: (1) Diagnosis of PCOS (Chinese Guidelines for Diagnosis and Treatment of Polycystic Ovary Syndrome (2018)). (2) The patient's BMI (body mass index) is greater than 32.5 kg/m^2; the patient's BMI (body mass index) is between 27.5-32.5 kg/m^2, and the patient has metabolic syndrome. (3) Premenopausal women between the ages of 18-45. (4) For patients with infertility, it is necessary to exclude infertility caused by abnormal fallopian tubes, uterus and spouse's semen examination (infertility standard: husband and wife live together, have normal sexual life, and have not conceived for 1 year). (5) Sign the informed consent. (6) Able to complete follow-up requirements. 2. Inclusion criteria for non-PCOS patients: (1) The diagnosis of PCOS has been excluded (Chinese Guidelines for Diagnosis and Treatment of Polycystic Ovary Syndrome (2018)). (2) The patient's BMI (body mass index) is greater than 32.5 kg/m^2; the patient's BMI (body mass index) is between 27.5-32.5 kg/m^2, and the patient has metabolic syndrome. (3) Premenopausal women between the ages of 18-45. (4) For patients with infertility, it is necessary to exclude infertility caused by abnormal fallopian tubes, uterus and spouse's semen examination (infertility standard: husband and wife live together, have normal sexual life, and have not conceived for 1 year). (5) Sign the informed consent. (6) Able to complete follow-up requirements.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to bariatric surgery or gastrointestinal bypass surgery. 2. Previous history of upper abdominal surgery. 3. The patient has other intractable diseases, or severe diabetes complications, or other major diseases [renal failure, liver cirrhosis, malignant tumor, chronic heart failure, recent (within 1 year) history of myocardial infarction, stroke, TIA]. 4. Other untreated endocrine diseases: diseases related to abnormal functions such as cortisol, adrenocorticotropic hormone, and thyroid function. 5. Active ulcers. 6. Known causes of hyperandrogenism and ovulation disorders due to other causes, these include 21-hydroxylase deficiency, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, thyroid disease, and hyperprolactinemia. 7. Poor compliance, lost to follow-up. 8. Those who have serious comorbidities or cannot continue the trial for other reasons.

Design outcomes

Primary

MeasureTime frame
menstrual cycle;

Secondary

MeasureTime frame
sex hormone;body mass index;waist-hip ratio;asprosin;serum lipid;blood glucose;inflammatory factor;ovarian ultrasound;pregnancy rate;abortion rate;preterm birth rates;vaginal flora;gut microbiota;

Countries

China

Contacts

Public ContactZhu Shaihong

The Third Xiangya Hospital of Central South University

shaihongzhu@126.com+86 18975186193

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026