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Recruiting 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

No phase Interventional Infertility and Miscarriage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcervical resection of septum.
Who it may be relevant to
Registry conditions: Infertility and Miscarriage. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Transcervical resection of septum
    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 outcome measures

  • Live birth rate [Time frame: within 12 months after initiating embryo transfer]
Secondary outcome measures (1)
  • Adverse outcome rate [Time frame: within 12 months after initiating embryo transfer in both groups]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07611656 · xy3-TCRS-IVF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗