Clinical trial · Interventional
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
NCT01637974CI-TRIAL-00018735unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asherman Syndrome | — | UNRESOLVED | — |
| Endometrial Polyp | Endometrial Polyp | ONTOLOGY_EXACT | 0.98 |
| Uterine Myoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INTERCOAT administration | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- with INTERCOAT
- description
- injection of intercoat into the euterine cavity at the end of hysteroscopy
- interventionNames
- Drug: INTERCOAT administration
- type
- NO_INTERVENTION
- label
- without INTERCOAT
- description
- without INTERCOAT
Primary outcomes (1)
- measure
- Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 50 years * Must be able to understand, read and sign consent form Exclusion Criteria: * Signs of infection upon admission * Ongoing pregnancy * Carcinoma of the uterus or cervix * Recurrent PID * Women admitted for endometrial ablation * Women that gave birth 6 weeks ago * Women participating in another study
References
Publications (0)
Data not yet available
No reference posted for this study.