Endobarrier Treatment in Women With PCOS

NCT02255578 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-10-02

No results posted yet for this study

Summary

Women with Polycystic ovary syndrome (PCOS) experience multiple fertility treatments, a long treatment duration and a low pregnancy prevalence. This syndrome is frequently accompanied by overweight and insulin resistance which can mediate the limited response to fertility treatment. The Endobarrier device was shown to be efficient in weight and glucose lowering. The aim of this study is to investigate the ability of the Endobarrier device to improve the outcome of fertility treatments in women with PCOS.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DEVICE

Endobarrier treatment in PCOS

the effect of an EndoBarrier device on fertility and metabolic parameters in obese insulin resistant (IR) PCOS women

DRUG

clomiphene citrate treatment

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Gabriella Lieberman, MD · Sheba Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-09-30
Completion
2018-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255578 on ClinicalTrials.gov