## Protocol Section
### Identification Module
**NCT ID:** NCT01377779

**Brief Title:** Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions

**Official Title:** Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study

#### Organization Study ID Info
**ID:** 2*13/09
#### Organization
**Class:** OTHER_GOV
**Full Name:** Assaf-Harofeh Medical Center
### Status Module
#### Completion Date
**Date:** 2011-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-06-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-06-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-11

**Type:** ACTUAL

#### Start Date
**Date:** 2009-09

**Status Verified Date:** 2009-07

#### Study First Post Date
**Date:** 2011-06-21
**Type:** ESTIMATED
**Study First Submit Date:** 2011-06-15
**Study First Submit QC Date:** 2011-06-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Assaf-Harofeh Medical Center

#### Responsible Party

**Old Name Title:** Moty Pansky, MD

**Old Organization:** Asaf Harofe MC

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.

**Detailed Description:** Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.

### Conditions Module

**Conditions:**

- Asherman Syndrome

**Keywords:**

- Oxiplex/AP gel

- Prevention of Asherman's syndrome

- Intra uterine adhesions

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** women treated by Intercoat gel following hysteroscopy for retained products of conception

**Intervention Names:**

- Drug: Oxiplex/AP gel

**Label:** Intercoat treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No additional treatment following hysteroscopy was performed

**Intervention Names:**

- Drug: Normal Saline

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intercoat treatment

**Description:** Intrauterine application of Intercoat following hysteroscopy

**Name:** Oxiplex/AP gel

**Other Names:**

- Intercoat

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** No intrauterine application of Intercoat following hysteroscopy

**Name:** Normal Saline

**Other Names:**

- Distention media

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern

**Measure:** safety of intrauterine application of Intercoat

**Time Frame:** 18 months

#### Secondary Outcomes

**Description:** intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment

**Measure:** efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception

**Time Frame:** 14 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age between 18 and 50 years
* Availability of the results of vaginal ultrasound or diagnostic hysteroscopy

Exclusion Criteria:

* Signs of infection upon admission
* Ongoing pregnancy

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zerifin

**Country:** Israel

**Facility:** Asaf Harofe MC

**Zip:** 70300

#### Overall Officials

**Official 1:**

**Affiliation:** Asaf Harofe MC

**Name:** Moty Pansky, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000002921

- Term: Cicatrix

- ID: D000005355

- Term: Fibrosis

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3620

- Name: Tissue Adhesions

- Relevance: HIGH

- As Found: Adhesion

- ID: M9269

- Name: Gynatresia

- Relevance: HIGH

- As Found: Asherman Syndrome

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T509

- Name: Asherman's Syndrome

- Relevance: HIGH

- As Found: Asherman Syndrome

### Condition Browse Module - Meshes

- ID: D000006175

- Term: Gynatresia

- ID: D000000267

- Term: Tissue Adhesions

### Misc Info Module

- Version Holder: 2024-05-24
