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Effectiveness of hysteroscopic niche resection versus expectant management in patients with secondary infertility and a small uterine caesarean scar defect on reproductive outcomes: a randomized controlled trial

Effectiveness of hysteroscopic niche resection versus expectant management in patients with secondary infertility and a small uterine caesarean scar defect on reproductive outcomes: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074922
Enrollment
Unknown
Registered
2023-08-21
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Cesarean scar defect

Interventions

Intervention group:Hysteroscopic niche resection

Sponsors

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

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1)Age 20-45 years uterus cesarean scar defect and desire to be pregnant (2)Unexplained infertility for at least one year; or failed IVF; or problems during fertility therapy, such as intrauterine accumulation of fluid or difficulties in transferring embryo (3)Cesearen scar niche detected by MRI (a myometrial defect of at least 2mm depth at the site of scar and a residual myometrium of more than 2.2mm) (4)Signed informed consent.

Exclusion criteria

Exclusion criteria: (1)Contraindication to surgery or anaesthesia (general or local) (2)Established pregnancy (3)Relevant treatment affecting the observed indicators within 3 months (4)Combined cervical dysplasia, acute infection of the pelvis or acute attack of chronic infection, suspected or known malignancy or combined benign lesions requiring hysterectomy ( atypical endometrial cells), dysfunction of coagulation,hydrosalpinx communicating with the uterus (5)Infertility caused by ovulatory dysfunction, tubal disorders, endometriosis and submucosal fibroids (6)With myomas and oophoritic cyst that should be treated by operation (7)Contraindication to pregnancy

Design outcomes

Primary

MeasureTime frame
Pregnancy to live birth rate;cost-effect quota;

Secondary

MeasureTime frame
pregnancy outcome;menstruation characteristics;imaging measurements;perioperative complications;

Countries

China

Contacts

Public ContactJinglan Liu

The International Peace Maternity and Child Health Hospital

jinglan.liu@163.com+86 180 1731 0157

Outcome results

None listed

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