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

NCT07611656 | Recruiting

• 1 other identifier: xy3-TCRS-IVF
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility and Miscarriage

Keywords

transcervical resection of septum; In Vitro Fertilization and Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Follow-up was conducted for 12 months after the surgery or treatment course to record the IVF/ICSI reproductive outcomes within 12 months after the initiation of embryo transfer into the cycle.

  within 12 months after initiating embryo transfer

Secondary Outcomes (1)

• Adverse outcome rate

  within 12 months after initiating embryo transfer in both groups

Study Arms (2)

Surgical group

EXPERIMENTAL

Undergoing hysteroscopic septectomy

Procedure: Transcervical resection of septum

Control group

NO INTERVENTION

Routine preconception counseling and observation without hysteroscopic septectomy

Interventions

Transcervical resection of septum PROCEDURE

Hysteroscopic surgery 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.

Surgical group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (1) Recurrent miscarriage; (2) Combined with untreated intramural uterine fibroids larger than 3 cm, intrauterine adhesions with an AFS score of ≥5 points; (3) Uncontrolled endocrine disorders, such as abnormal thyroid function (FT3, FT4 abnormal), hyperprolactinemia (greater than 2 times the upper limit of normal), combined with atypical endometrial hyperplasia or malignant lesions, acute inflammation of the reproductive system, coagulation dysfunction, etc.; if combined with endometrial polyps or submucosal fibroids, they can still be included in the group after resection; (4) Combined with adenomyosis (uterine body\>50 days of pregnancy), chocolate cysts with a diameter of\>4 cm, or severe dysmenorrhea and clear DIE lesions (diameter\>1 cm) can be palpated by gynecological triple examination; (5) Untreated severe hydrosalpinx (diameter\>3 cm) or hydrosalpinx with reflux confirmed by ultrasound; (6) Other important organ diseases and other surgical contraindications or relative contraindications; other conditions that are not suitable for assisted reproductive treatment; (7) Have participated in other interventional clinical studies (within the last three months).

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Peking Union Medical College Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Maternal and Child Health Hospital of Hubei Province: collaborator
• The First People's Hospital of Yunnan: collaborator
• Tianjin Medical University General Hospital: collaborator
• Guangzhou First People's Hospital: collaborator
• Gansu Maternal and Child Health Hospital: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• The First Hospital of Jilin University: collaborator
• Beijing Tiantan Hospital: collaborator
• Tongji Hospital: collaborator
• Xijing Hospital: collaborator
• Southwest Hospital, China: collaborator
• Beijing Fuxing Hospital: collaborator
• Hospital for Reproductive Medicine Affiliated to Shandong University: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Dabao Xu

CONTACT

13017386201; forxudabao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: May 28, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 28, 2026

Record last verified: 2025-06

Locations

CN (1)