Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect (TVARES)

Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect (niche), a Randomised Controlled Trial

The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are:

1. Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility?
2. What medical problems do participants have when taking transvaginal niche resection?

Researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility.

Participants will:

1. Undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. Women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy.
2. Receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. Patients are allowed to become pregnant and to receive fertility therapies if indicated. Any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection.
3. Receive a standardized magnetic resonance imaging (MRI) evaluation of the niches. Niches will be evaluated at baseline in all groups and at 3 months after surgery.
4. Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Caesarean Scar Defect
• Intervention / Treatment: Procedure: Transvaginal niche resection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qunying Cai; Phone Number: 086 13621906294; Email: invain05@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. It was diagnosed by MRI as a large niche (defined as niche with a depth of >50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm);
2. Infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed IVF);
3. Fertility requirements;
4. Signed informed consent.

Exclusion Criteria:

1. Age below 18 years or over 49 years;
2. Contraindications for intraspinal or general anaesthesia;
3. A (suspected) malignancy or combined benign lesions requiring hysterectomy;
4. Atypical endometrial cells or cervical dysplasia;
5. Uterine or cervical polyps;
6. Submucosal fibroids;
7. Hydrosalpinx.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transvaginal niche resection; The patients assigned to the intervention group will undergo a procedure under general anaesthesia in lithotomy position.	Procedure: Transvaginal niche resection; In short: the bladder was carefully dissected away from the uterus towards the abdominal cavity to open the vesicovaginal space and reach the peritoneum. The fingers on the anterior wall isthmus could touch the obvious scar-like defect. The weak scar tissue then thoroughly was removed.
No Intervention: Standard of care; The patients assigned to the control group will receive usual care at least 9 months which means no additional surgical intervention during this period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate	Live birth is defined as a live born neonate beyond 24 weeks of gestation.	Total follow-up will extend to 15 months after randomization.

Collaborators and Investigators

• Sponsor: International Peace Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: caesarean scar defect
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: IIT-2023-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No