Endobarrier Treatment in Women With PCOS

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Zuclomiphene

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.