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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01637974

Enrollment

130

Registered

2012-07-11

Start date

2012-12-31

Completion date

2016-03-31

Last updated

2015-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asherman Syndrome, Endometrial Polyp, Uterine Myoma

Brief summary

The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.

Interventions

DRUGINTERCOAT administration

Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy	one year

Countries

Israel

Contacts

Primary ContactMoran PAZ, M.D.

MORANPA@CLALIT.GOV.IL972-4-8250637

Backup ContactYuval Kaufman, M.D.

mdykaufman@clalit.org.il972-4-8250345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026