Intrauterine Stent Placement Following Hysteroscopic Septum Resection

Not Applicable

Not yet recruiting

• Conditions: Intrauterine Adhesion
• Interventions: Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter; Procedure: No Catheter placement; Drug: Hormonal Therapy Agent; Drug: Oral antibiotics

• Registration Number: NCT07032506
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.

Detailed Description

This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.

Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:

Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. Intra-operative photographs will be taken at the start of and the end of the procedure and placed in the patient's medical chart for review. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess outcome and adhesion formation within the first two menstrual cycles following the intervention, or within12 weeks following surgery. Sonogram images will be reviewed for intrauterine adhesion formation by a third party who is blinded to the intervention received.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-14
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-27
• Primary Completion: 2028-01-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

• Age 18 and above
• Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
• Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound

Exclusion Criteria

• Unwilling or unable to provide informed consent
• History of prior uterine septum resection
• History of prior transmural uterine surgery
• Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
• Individuals in whom complete septum resection is unable to be performed as a single procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter	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.
Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter	Hormonal Therapy Agent	Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter	Oral antibiotics	Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter	No Catheter placement	No placement of an inflated intrauterine pediatric foley catheter
Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter	Hormonal Therapy Agent	No placement of an inflated intrauterine pediatric foley catheter

Primary Outcome Measures

Name	Time	Method
The rate of intrauterine adhesion formation following hysteroscopic septoplasty	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with Intraoperative complications	12 weeks
Number of participants with postoperative complications	12 weeks
Number of subjects completing postop intervention-hormone use	12 weeks
Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit	12 weeks
Long Term Reproductive Outcome	3 years	Number of subjects achieving pregnancy
Surgeon assessment of intervention modality	12 weeks	Surgeon assessment of whether intrauterine adhesions were prevented

Trial Locations

Locations (3)

Arkansas Fertility & Gynecology; 🇺🇸 Little Rock, Arkansas, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

University Hospitals; 🇺🇸 Cleveland, Ohio, United States