Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02404454

Enrollment

Registered

2015-03-31

Start date

2016-06-30

Completion date

2017-03-31

Last updated

2016-03-09

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

Conditions

Intrauterine Adhesions, Septate Uterus

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.

Interventions

PROCEDUREHysteroscopic metroplasty

DEVICEAutocross-linked acid hyaluronic gel

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

PROCEDUREOffice second look hysteroscopy

Second-look hysteroscopy after three months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame
Change in Formation of intrauterine adhesions	baseline (operative isteroscopy and three months

Outcome results

None listed

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