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

NCT06599671 | Not Yet Recruiting DMC

• 1 other identifier: IIT-2023-10
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility?
2. 2.What medical problems do participants have when taking transvaginal niche resection?
3. 3.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.
4. 4.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.
5. 5.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.
6. 6.Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.

Conditions

Caesarean Scar Defect

Keywords

caesarean scar defect

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Transvaginal niche resection

EXPERIMENTAL

The patients assigned to the intervention group will undergo a procedure under general anaesthesia in lithotomy position.

Procedure: Transvaginal niche resection

Standard of care

NO INTERVENTION

The patients assigned to the control group will receive usual care at least 9 months which means no additional surgical intervention during this period.

Interventions

Transvaginal niche resection PROCEDURE

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.

Transvaginal niche resection

Eligibility Criteria

• Age: 19 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• Infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed IVF);
• Fertility requirements;
• Signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Central Study Contacts

Qunying Cai

CONTACT

086 13621906294; invain05@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share