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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400093622

Enrollment

Unknown

Registered

2024-12-09

Start date

2025-01-01

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine caesarean scar defect (niche)

Interventions

Intervention group:Transvaginal niche resection

Control group:Expectant management

Eligibility

Sex/Gender

Female

Age

19 Years to 48 Years

Inclusion criteria

Inclusion criteria: (1) It was diagnosed by MRI as a large niche (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

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.

Design outcomes

Primary

Measure	Time frame
Live birth rate;	—

Secondary

Measure	Time frame
Clinical pregnancy rate;Ongoing pregnancy rate;	—

Countries

China

Contacts

Public ContactQunying Cai

The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University

invain05@163.com+86 136 2190 6294

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026