Intrauterine Stent Placement Following Hysteroscopic Septum Resection

NANot yet recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

December 31, 2031

Conditions
Intrauterine Adhesion
Interventions
PROCEDURE

Intraoperative placement of an inflated intrauterine pediatric foley catheter

Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.

PROCEDURE

No Catheter placement

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

DRUG

Hormonal Therapy Agent

2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily)

DRUG

Oral antibiotics

100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place

Trial Locations (3)

10021

Weill Cornell Medicine, New York

44195

University Hospitals, Cleveland

72205-0000

Arkansas Fertility & Gynecology, Little Rock

All Listed Sponsors
lead

Weill Medical College of Cornell University

OTHER

NCT07032506 - Intrauterine Stent Placement Following Hysteroscopic Septum Resection | Biotech Hunter | Biotech Hunter