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

Effect of Laparoscopic Sleeve Gastrectomy (LSG) on Live Birth Rate of Offspring in Polycystic Ovarian Syndrome (PCOS) Patients With Severely Obese

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04151459
Enrollment
18
Registered
2019-11-05
Start date
2019-01-16
Completion date
2022-01-15
Last updated
2019-11-05

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

Conditions

Laparoscopic Sleeve Gastrectomy, Polycystic Ovary Syndrome, Severe Obesity

Keywords

Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy, Live Birth Rate

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.

Interventions

DRUGMetformin

Use Metformin for 3 months to treat PCOS

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.up to 3 yearsTo record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery

Secondary

MeasureTime frameDescription
Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patientsup to 3 yearsTo 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 yearsTo compare the intestinal flora of PCOS patients after metabolic surgery

Countries

China

Contacts

Primary ContactTao Tao, MD
taotaozhen@hotmail.com+86-13817701776
Backup ContactYuchen Zhu, Master
zhuyuchen_cc@163.com+86-13817946105

Outcome results

None listed

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