NCT02404454

Brief Summary

The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility. Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty. Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

March 26, 2015

Last Update Submit

March 8, 2016

Conditions

Intrauterine AdhesionsSeptate Uterus

Outcome Measures

Primary Outcomes (1)

  • Change in Formation of intrauterine adhesions

    baseline (operative isteroscopy and three months

Study Arms (1)

hysteroscopic metroplasty

EXPERIMENTAL

women undergoing hysteroscopic metroplasty for uterine septum resection

Procedure: Hysteroscopic metroplastyDevice: Autocross-linked acid hyaluronic gelProcedure: Office second look hysteroscopy

Interventions

Hysteroscopic metroplastyPROCEDURE
hysteroscopic metroplasty
Autocross-linked acid hyaluronic gelDEVICE

Patients received adhesion barrier with 5 ml of autocross-linked acid hyaluronic gel

hysteroscopic metroplasty
Office second look hysteroscopyPROCEDURE

Second-look hysteroscopy after three months

hysteroscopic metroplasty

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • uterine septum
  • history of ≥1 miscarriage or infertility;
  • desire to have children in the future

You may not qualify if:

  • pregnancy;
  • menopause;
  • precancerous state or malignancy of the reproductive organs;
  • benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
  • lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
  • withdrawal of patient consent;
  • rare complex uterine congenital anomalies without an ASRM classification such as uterine septum with double cervix ;
  • presence of external intercornual cleft;
  • incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively
  • excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GynatresiaSeptate Uterus

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine Duplication AnomaliesUterine Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

March 9, 2016

Record last verified: 2016-03