NCT04972032

Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Limin Feng · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.

Detailed description

Patients suspect to be suffering from IUA will be recruited following a systematic pre-operative assessment process. This will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3D transvaginal ultrasound. The severity and extent of intrauterine adhesions will be scored according to the AFS score. All patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. After adhesiolyis, the patients will assigned to two groups randomly,namely,the E-IUS(estrogen intrauterine stent system) group and the control group. Adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
DEVICE	Estrogen Intrauterine Stent System	A Estrogen Intrauterine Stent System（E-IUS）will be introduced post-operatively. The E-IUS will be removed 60 days after surgery with continuous dydrogesterone administration for 5 days at 20 mg/d, and routine management.
DEVICE	Foley balloon combined with self-cross-link sodium hyaluronate gel	Foley balloon combined with self-crosslinking sodium hyaluronate gel will be introduced post-operatively，2 cycles of estrogen-progestin sequential therapy comprised of continuous estrogen and progestin added in the second half of the cycle or continuous estradiol valerate for 60 days, followed by dydrogesterone for 10 days

Timeline

• Start date: 2020-09-02
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2021-07-22
• Last updated: 2021-09-17

Locations

1 site across 1 country: China