Endobarrier Treatment in Women With PCOS

NCT02255578 | Unknown Phase 3

• 1 other identifier: SHEBA-14-1170-GL-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• change in egg quality or ovulation rate after Endobarrier treatment

  Different fertility parameters will be tested during IVF treatment after endobarrier treatment: Total number of retrieved oocytes, Number of oocytes in M2, Number of 2PN, Top quality embryos on day of transfer, Number of embryos transferred Number of follicles above 15 mm,E2 on day of HCG, Number of embryos frozen. Ovulation in response to Clomiphene citrate will also be assessed.

  2.5 years

Secondary Outcomes (7)

• percent change in LDL cholesterol

  6 months

• percent change in HDL cholesterol

  6 months

• percent change in Triglycerides

  6 months

• percent change in HbA1c

  6 months

• percent change in fasting plasma glucose levels

  6 months

Study Arms (2)

IVF treatment

OTHER

Fertility, as determined by egg quality parameters, as well as metabolic parameters, will be assessed following Endobarrier treatment in PCOS during IVF treatment.

Device: Endobarrier treatment in PCOS

clomiphene citrate treatment

OTHER

Ovulation rate in response to clomiphen citrate after Endobarrier treatment in PCOS.

Device: Endobarrier treatment in PCOS; Drug: clomiphene citrate treatment

Interventions

Endobarrier treatment in PCOS DEVICE

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

IVF treatment; clomiphene citrate treatment

clomiphene citrate treatment DRUG

clomiphene citrate treatment

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women willing to comply with study requirements and have signed an informed consent form.
• Age 20-35
• BMI ≥ 35 kg/m²
• A history of failed IVF treatment cycle/s or resistance to ovulation induction with clomiphene citrate.
• Documented negative pregnancy test.
• Women agree to remain on contraceptives as long as the Endobarrier is intact.
• PCOS as defined by at least two of the following criteria:
• IGT as defined by: the ratio of fasting glucose to fasting insulin \<4.5, and/or 2-hour glucose level after a 75-g oral glucose tolerance test between 140-199 mg/dL.
• Documented FSH levels below 12 IU/L, from any source taken no longer than 3 months before screening.

You may not qualify if:

• Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization
• Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to the Endobarrier insertion procedure (including GLP-1 analogs).
• Known Diabetes as defined by: fasting plasma glucose ≥126 mg/dL or any plasma glucose ≥200 mg/dL or HbA1c level ≥6.5% .
• Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant
• Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the Investigator, may impair implantation of the EndoBarrier device
• Subjects with active GERD not taking a Proton Pump Inhibitor (PPI), which in the investigator's opinion might interfere with the Endobarrier.
• Subjects with symptomatic kidney stones within 6 months prior to randomization.
• Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions
• Subjects with symptomatic gallstones within 6 months prior to randomization
• Coagulopathy defined as hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
• Any documented history of acute or chronic pancreatitis
• Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
• Subjects unable to discontinue Aspirin or any other NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect (i.e coumadin) during the study duration
• Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 526210, Israel

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Gabriella Lieberman, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Lieberman, MD

CONTACT

972-3-5302021; gebriella.lieberman@sheba.health.gov.il

Ayana Paster, MD

CONTACT

endo.r@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: October 2, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: October 2, 2014

Record last verified: 2014-09

Locations

IL (1)