Status:
NOT_YET_RECRUITING
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
Lead Sponsor:
International Peace Maternity and Child Health Hospital
Conditions:
Caesarean Scar Defect
Eligibility:
FEMALE
19-48 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06599671
Start Date
October 1 2024
End Date
September 30 2027
Last Update
September 24 2024
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