A Multicenter, Prospective, Randomized, Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on the Natural Pregnancy Outcomes in Patients With Non-recurrent Spontaneous Abortion

Summary

The study aims to compare the effects of transcervical resection of septa (TCRS) and expectant management on the natural pregnancy outcomes of patients with septate uterus without recurrent abortion, also covering the treatment of other infertility factors in infertile patients who aim at natural conception. The research attempts to answer whether TCRS can improve the live birth rate, pregnancy rate and pregnancy outcomes for septate uterus patients planning natural pregnancy, so as to provide evidence-based medical evidence for the selection of clinical treatment methods for such patients.

Conditions

• Infertility and Miscarriage

Interventions

PROCEDURE

Transcervical resection of septum

Transcervical resection of septum (TCRS) is divided into two categories: one is plasma hysteroscopic electrosurgical resection (actually TCIS), which uniformly uses a 7mm external diameter hysteroscopic electrosurgical resectoscope to reduce the difficulty of cervical dilation; the other is micro (5 or 7Fr) hysteroscopic cold knife incision, equipped with a 5Fr bipolar electrocoagulation stick for electrocoagulation and hemostasis.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Maternal and Child Health Hospital of Hubei Province

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Beijing Fuxing Hospital

  collaborator UNKNOWN

• Tongji Hospital

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Hospital for Reproductive Medicine Affiliated to Shandong University

  collaborator UNKNOWN

• Guangzhou First People's Hospital

  collaborator OTHER

• Gansu Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2028-12-31

Completion

2030-06-01

Countries

• China

Study Locations