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NCT Number: NCT07039097

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

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.

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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]

13327215012

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) The patient meets the 2024 ASRM diagnostic criteria for uterine septate after three-dimensional color Doppler ultrasound examination; (2) The patient may have never been pregnant, or may have a history of live birth, one biochemical pregnancy, or one fetal arrest. The patient may also be an infertile patient who wishes to conceive naturally, such as a patient with hydrosalpinx and laparoscopic stoma, or a patient whose infertility factors can be treated; (3) The patient is between 20 and 40 years old; (4) The patient plans to try to conceive naturally to achieve the desire to have a baby; (5) The patient has normal ovarian reserve function (AMH>1.1ng/ml, FSH<12U/L on the 2nd to 5th day of menstruation); (6) The male's semen is generally normal; (7) The patient signs the informed consent form and is able to accept and adhere to treatment and follow-up. Patients in the control group can undergo hysteroscopy or hystero-laparoscopy to treat other problems, but septal resection is not performed.

Exclusion criteria

  • (1) Recurrent miscarriage; (2) Patients with intramural uterine myoma larger than 3 cm, moderate to severe intrauterine adhesions; (3) Uncontrolled endocrine disorders, such as abnormal thyroid function (FT3, FT4 abnormal), hyperprolactinemia (greater than 2 times the upper limit of normal), uncontrolled endometrial hyperplasia, EIN or malignant lesions, acute inflammation of the reproductive system, coagulation dysfunction, etc.; if combined with endometrial polyps or submucosal myoma, patients can still be included in the group after resection; (4) Patients 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 during gynecological triple examination; (5) Untreated bilateral hydrosalpinx or obstruction; (6) Other important organ diseases and other surgical contraindications or relative contraindications. Other situations that are not suitable for assisted reproductive treatment. Those who have participated in other clinical research (within the past three months); (7) Those who are assessed to need IVF (e.g., those whose fallopian tubes cannot be cleared, or whose ovulation dysfunction cannot be treated with medication, etc.).

Treatment and study plan

Transcervical resection of septum

Procedure

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.

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 Provincial Maternal and Child Health Care 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
2028
Study completion
2030
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

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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