NCT04151459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

October 15, 2019

Last Update Submit

November 2, 2019

Conditions

Polycystic Ovary SyndromeSevere ObesityLaparoscopic Sleeve Gastrectomy

Keywords

Polycystic Ovary SyndromeSevere ObesityLaparoscopic Sleeve GastrectomyLive Birth Rate

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 3 years

Secondary Outcomes (2)

  • Effect of metabolic surgery on ovulation rate and pregnancy rate of PCOS patients

    up to 3 years

  • Effects of metabolic surgery on intestinal flora of PCOS patients and progeny.

    up to 3 years

Study Arms (1)

Laparoscopic sleeve gastrectomy

EXPERIMENTAL

Laparoscopic sleeve gastrectomy on severe obesity PCOS patients

Drug: Metformin

Interventions

MetforminDRUG

Use Metformin for 3 months to treat PCOS

Also known as: Glucophage
Laparoscopic sleeve gastrectomy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23814096BACKGROUND

  • Jarrett BY, Lujan ME. Impact of hypocaloric dietary intervention on ovulation in obese women with PCOS. Reproduction. 2017 Jan;153(1):R15-R27. doi: 10.1530/REP-16-0385.

    PMID: 27799625BACKGROUND

  • 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.

    PMID: 27052492BACKGROUND

  • 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.

    PMID: 26431698BACKGROUND

  • 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.

    PMID: 24694334BACKGROUND

  • Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.

    PMID: 24880830BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesity, Morbid

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Tao Tao, MD

    RenJi Hospital Department of Endocrinology and Metabolism

    STUDY CHAIR

Central Study Contacts

Tao Tao, MD

CONTACT

+86-13817701776taotaozhen@hotmail.com

Yuchen Zhu, Master

CONTACT

+86-13817946105zhuyuchen_cc@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2019

First Posted

November 5, 2019

Study Start

January 16, 2019

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)