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NCT02255578: EPCOS
Phase 3 Study Investigating the Effect of Endobarrier Treatment on Fertility in Women With Polycystic Ovary Syndrome
Phase 3 trial testing Endobarrier treatment in PCOS in Polycystic Ovary Syndrome in 50 participants. Status unknown.
1 September 2017
Quick facts
| Lead sponsor | Sheba Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 September 2014 |
| Primary completion | 1 September 2017 |
| Estimated completion | 1 September 2018 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Endobarrier treatment in PCOS
- clomiphene citrate treatment — full drug profile →
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Sponsor
Sheba Medical Center
Who can join
Adults 20 to 35, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02255578
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polycystic Ovary Syndrome
Currently open trials in the same condition.
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- NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
- NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
- NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting
Other Sheba Medical Center trials
Trials by the same sponsor.
- NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
- NCT07523373 — Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch · NA · not yet recruiting
- NCT07509229 — 9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients · Phase 1, PHASE2 · not yet recruiting
- NCT07405723 — Arm Position and Blood Pressure Measurement Accuracy During Pregnancy · NA · recruiting
- NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02255578 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sheba Medical Center
- Last refreshed: 29 September 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02255578.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing