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Endobarrier Treatment in Women With PCOS (EPCOS)

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ClinicalTrials.gov Identifier: NCT02255578
Recruitment Status : Unknown
Verified September 2014 by Dr. Gabriella Segal-Lieberman, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Gabriella Segal-Lieberman, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Device: Endobarrier treatment in PCOS Drug: clomiphene citrate treatment Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study Investigating the Effect of Endobarrier Treatment on Fertility in Women With Polycystic Ovary Syndrome
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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

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



Primary Outcome Measures :
  1. change in egg quality or ovulation rate after Endobarrier treatment [ Time Frame: 2.5 years ]
    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.


Secondary Outcome Measures :
  1. percent change in LDL cholesterol [ Time Frame: 6 months ]
  2. percent change in HDL cholesterol [ Time Frame: 6 months ]
  3. percent change in Triglycerides [ Time Frame: 6 months ]
  4. percent change in HbA1c [ Time Frame: 6 months ]
  5. percent change in fasting plasma glucose levels [ Time Frame: 6 months ]
  6. percent change in body mass index [ Time Frame: 6 months ]
  7. percent change in waist circumference [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Women willing to comply with study requirements and have signed an informed consent form.
  2. Age 20-35
  3. BMI ≥ 35 kg/m²
  4. A history of failed IVF treatment cycle/s or resistance to ovulation induction with clomiphene citrate.
  5. Documented negative pregnancy test.
  6. Women agree to remain on contraceptives as long as the Endobarrier is intact.
  7. PCOS as defined by at least two of the following criteria:

    A. Polycystic ovaries. B. Oligo and/or anovulation C. Clinical (i.e acne, hirsutism) and/or biochemical signs of hyperandrogenism (i.e high levels of Testosterone, Androstendione, 17-hydroxyprogesterone, DHEA-S) and exclusion of other etiologies (congenital adrenal hyperplasia androgen-secreting tumors, Cushing's syndrome).

  8. 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.
  9. Documented FSH levels below 12 IU/L, from any source taken no longer than 3 months before screening.

Exclusion Criteria:

  1. Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization
  2. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to the Endobarrier insertion procedure (including GLP-1 analogs).
  3. Known Diabetes as defined by: fasting plasma glucose ≥126 mg/dL or any plasma glucose ≥200 mg/dL or HbA1c level ≥6.5% .
  4. Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant
  5. 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
  6. Subjects with active GERD not taking a Proton Pump Inhibitor (PPI), which in the investigator's opinion might interfere with the Endobarrier.
  7. Subjects with symptomatic kidney stones within 6 months prior to randomization.
  8. Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions
  9. Subjects with symptomatic gallstones within 6 months prior to randomization
  10. Coagulopathy defined as hgb <10g/dl and platelet < 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
  11. Any documented history of acute or chronic pancreatitis
  12. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
  13. 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
  14. Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  15. Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study
  16. Subjects with poor dentition who cannot completely chew their food.
  17. Subjects with thyroid disease unless controlled with a therapeutic dose of medication and have normal thyroid function tests for a minimum of 6 months prior to randomization
  18. Subjects not residing within a 3 hour driving distance of the study center.
  19. Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study
  20. Subjects with known allergies or hypersensitivity to ceftrixone, cephalosporins or penicillin.
  21. The investigator may decide to exclude the participation of a subject due to medical, safety or any other reason (i.e; behavioral issues, etc.) at any point before the implantation procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255578


Contacts
Contact: Gabriella Lieberman, MD 972-3-5302021 gebriella.lieberman@sheba.health.gov.il
Contact: Ayana Paster, MD endo.r@sheba.health.gov.il

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel, 526210
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Gabriella Lieberman, MD Sheba Medical Center

Responsible Party: Dr. Gabriella Segal-Lieberman, Endocrinologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02255578     History of Changes
Other Study ID Numbers: SHEBA-14-1170-GL-CTIL
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators