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A Multicenter, Prospective, Randomized Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on IVF-ET Outcomes in Infertile Patients With Non-recurrent Miscarriage

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. The research attempts to answer: for infertile women with uterine septum planning to undergo IVF/ICSI (excluding preimplantation genetic diagnosis), does TCRS improve pregnancy outcomes (such as live birth rate, pregnancy rate, miscarriage rate, etc.) compared to non-surgical treatment (conservative observation), and to clarify the clinical value and safety of this surgical intervention.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• (1) Meet the 2024 ASRM diagnostic criteria for uterine septate after 3D color Doppler ultrasound examination; (2) Aged between 20 and 40 years old; (3) Meet the diagnosis of infertility: those who have had regular sexual intercourse for at least 12 months but have not achieved clinical pregnancy; (4) Plan to undergo IVF/ICSI (non-PGD); (5) Sign the informed consent form and be able to accept and adhere to treatment and follow-up.

Locations
Other Locations
China
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Dabao Xu
forxudabao@126.com
13017386201
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2030-06-01
Participants
Target number of participants: 236
Treatments
Experimental: Surgical group
Undergoing hysteroscopic septectomy
No_intervention: Control group
Routine preconception counseling and observation without hysteroscopic septectomy
Related Therapeutic Areas
Sponsors
Collaborators: Anhui Provincial Hospital, Peking Union Medical College Hospital, Maternal and Child Health Hospital of Hubei Province, Xijing Hospital, Beijing Tiantan Hospital, Women's Hospital School Of Medicine Zhejiang University, Obstetrics & Gynecology Hospital of Fudan University, Shandong University, Tongji Hospital, Tianjin Medical University General Hospital, The First Hospital of Jilin University, The First People's Hospital of Yunnan, Southwest Hospital, China, Guangzhou First People's Hospital, Beijing Fuxing Hospital, Gansu Maternal and Child Health Hospital
Leads: The Third Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov