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

Primary Purpose

Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metformin
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy, Live Birth Rate

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic sleeve gastrectomy

Arm Description

Laparoscopic sleeve gastrectomy on severe obesity PCOS patients

Outcomes

Primary Outcome Measures

Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.
To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery

Secondary Outcome Measures

Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients
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.
To compare the intestinal flora of PCOS patients after metabolic surgery

Full Information

First Posted
October 15, 2019
Last Updated
November 2, 2019
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04151459
Brief Title
Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients
Official Title
Effect of Laparoscopic Sleeve Gastrectomy (LSG) on Live Birth Rate of Offspring in Polycystic Ovarian Syndrome (PCOS) Patients With Severely Obese
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy
Keywords
Polycystic Ovary Syndrome, Severe Obesity, Laparoscopic Sleeve Gastrectomy, Live Birth Rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopic sleeve gastrectomy on severe obesity PCOS patients
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
Use Metformin for 3 months to treat PCOS
Primary Outcome Measure Information:
Title
Improvement of metabolic surgery on live birth rate of offspring in obesity PCOS patients.
Description
To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients
Description
To compare the ovulation rate and pregnancy of obesity PCOS patient with metabolic surgery or not
Time Frame
up to 3 years
Title
Effects of metabolic surgery on intestinal flora of PCOS patients and progeny.
Description
To compare the intestinal flora of PCOS patients after metabolic surgery
Time Frame
up to 3 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Tao, MD
Phone
+86-13817701776
Email
taotaozhen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuchen Zhu, Master
Phone
+86-13817946105
Email
zhuyuchen_cc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Tao, MD
Organizational Affiliation
RenJi Hospital Department of Endocrinology and Metabolism
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Tao, Doctor
Phone
+86-13817701776
Email
taotaozhen@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23814096
Citation
Li R, Zhang Q, Yang D, Li S, Lu S, Wu X, Wei Z, Song X, Wang X, Fu S, Lin J, Zhu Y, Jiang Y, Feng HL, Qiao J. Prevalence of polycystic ovary syndrome in women in China: a large community-based study. Hum Reprod. 2013 Sep;28(9):2562-9. doi: 10.1093/humrep/det262. Epub 2013 Jun 27.
Results Reference
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PubMed Identifier
27799625
Citation
Jarrett BY, Lujan ME. Impact of hypocaloric dietary intervention on ovulation in obese women with PCOS. Reproduction. 2016 Oct 31:REP-16-0385. doi: 10.1530/REP-16-0385. Online ahead of print.
Results Reference
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PubMed Identifier
27052492
Citation
Behboudi-Gandevani S, Ramezani Tehrani F, Rostami Dovom M, Farahmand M, Bahri Khomami M, Noroozzadeh M, Kabir A, Azizi F. Insulin resistance in obesity and polycystic ovary syndrome: systematic review and meta-analysis of observational studies. Gynecol Endocrinol. 2016;32(5):343-53. doi: 10.3109/09513590.2015.1117069. Epub 2016 Jan 6.
Results Reference
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PubMed Identifier
26431698
Citation
Skubleny D, Switzer NJ, Gill RS, Dykstra M, Shi X, Sagle MA, de Gara C, Birch DW, Karmali S. The Impact of Bariatric Surgery on Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis. Obes Surg. 2016 Jan;26(1):169-76. doi: 10.1007/s11695-015-1902-5.
Results Reference
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PubMed Identifier
24694334
Citation
Niu Z, Lin N, Gu R, Sun Y, Feng Y. Associations between insulin resistance, free fatty acids, and oocyte quality in polycystic ovary syndrome during in vitro fertilization. J Clin Endocrinol Metab. 2014 Nov;99(11):E2269-76. doi: 10.1210/jc.2013-3942. Epub 2014 Apr 2.
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Results Reference
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Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients

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