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NCT Number: NCT07611656

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Dabao Xu

CONTACT

[email protected]

13017386201

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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).

Treatment and study plan

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.

Primary outcomes

  1. Live birth rate

    Time frame: within 12 months after initiating embryo transfer

    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.

Secondary outcomes

  1. Adverse outcome rate

    Time frame: within 12 months after initiating embryo transfer in both groups

    Pregnancy rate and cumulative pregnancy rate, miscarriage rate and cumulative miscarriage rate, preterm birth rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Dabao Xu

CONTACT

[email protected]

13017386201

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • Anhui Provincial Hospital
  • Beijing Tiantan Hospital
  • Fu Xing Hospital, Capital Medical University
  • Gansu Maternal and Child Health Hospital
  • Guangzhou First People's Hospital
  • Maternal and Child Health Hospital of Hubei Province
  • Obstetrics & Gynecology Hospital of Fudan University
  • Peking Union Medical College Hospital
  • Shandong University
  • Southwest Hospital, China
  • The First Hospital of Jilin University
  • The First People's Hospital of Yunnan
  • Tianjin Medical University General Hospital
  • Tongji Hospital
  • Women's Hospital School Of Medicine Zhejiang University
  • Xijing Hospital

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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