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

NCT07039097 | Recruiting

• 1 other identifier: xy3-TCRS-NP
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transcervical resection of septum; Natural Pregnancy

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 Transcervical resection of septum

Procedure: Transcervical resection of septum

Control group

NO INTERVENTION

Routine preconception counseling and observation without hysteroscopic septectomy

Interventions

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.

Surgical group

Eligibility Criteria

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

You may qualify if:

• (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.

You may not qualify if:

• (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.).

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Peking Union Medical College Hospital: collaborator
• Maternal and Child Health Hospital of Hubei Province: collaborator
• Beijing Tiantan Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Beijing Fuxing Hospital: collaborator
• Tongji Hospital: collaborator
• The First People's Hospital of Yunnan: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• Southwest Hospital, China: collaborator
• The First Hospital of Jilin University: collaborator
• Tianjin Medical University General Hospital: collaborator
• Xijing Hospital: collaborator
• Hospital for Reproductive Medicine Affiliated to Shandong University: collaborator
• Guangzhou First People's Hospital: collaborator
• Gansu Provincial Maternal and Child Health Care Hospital: 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: June 26, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (1)