Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients

Not Applicable

• Conditions: Polycystic Ovary Syndrome; Severe Obesity; Laparoscopic Sleeve Gastrectomy
• Interventions: Drug: Metformin

• Registration Number: NCT04151459
• Lead Sponsor: RenJi Hospital

Brief Summary

This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring.

Detailed Description

The investigators designed a single center small sample exploratory study to clear the therapeutic effects of laparoscopic sleeve gastrectomy on live birth rate improvements of overweight/obese PCOS patients. The investigators plan to enroll 18 patients. Inclusion criteria: 1) Patients who are aged from 18 to 45, not menopause;2) have PCOS which is diagnosed according to 2003 Rotterdam criteria; 3) have been treated with behavioral and drugs intervention for 3 months but are ineffective; 4) have steady or steady weight gain over 5 years, BMI\>35kg/m2, or BMI\>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome.

Patients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (\>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; surgical contraindications are excluded.

Then the investigators plan to perform laparoscopic sleeve gastrectomy . Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients are followed up every 3 months until the end of the program. All patients receive MRI plain scan of upper and lower abdomen, oral glucose tolerance test (OGTT) and insulin, C-peptide releasing test again every 6 months after the operation. One year after the operation, patients would be evaluated whether they are suitable for pregnancy preparation and record the pregnancy mode. After pregnancy, various indicators would be closely monitored, including maternal vitamin and trace element levels.The birth of children and the live birth rate would be recorded.

The investigators will compare the data and finally identify the treatment effect of laparoscopic sleeve gastrectomy on overweight/obese PCOS patients.

Study Timeline

• Study Start: 2019-01-16
• Study First Submitted: 2019-10-15
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-02
• Last Update Submitted: 2019-11-02
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• aged from 18 to 45, not menopause have PCOS which is diagnosed according to 2003 Rotterdam criteria have been treated with behavioral and drugs intervention for 3 months but are ineffective have steady or steady weight gain over 5 years, BMI>35kg/m2, or BMI>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome

Exclusion Criteria

• Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) high blood pressure (>160/100mmHg) active infection secondary diabetes pregnancy alcohol abuse surgical contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic sleeve gastrectomy	Metformin	Laparoscopic sleeve gastrectomy on severe obesity PCOS patients

Primary Outcome Measures

Name	Time	Method
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.	up to 3 years	To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery

Secondary Outcome Measures

Name	Time	Method
Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients	up to 3 years	To compare the ovulation rate and pregnancy of obesity PCOS patient with metabolic surgery or not
Effects of metabolic surgery on intestinal flora of PCOS patients and progeny.	up to 3 years	To compare the intestinal flora of PCOS patients after metabolic surgery

Trial Locations

Locations (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China