Hysteroscopic Septum Resection to Improve IVF-ET Outcomes in Infertile Women with a Uterine Septum

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study prospectively compares hysteroscopic transcervical resection of the septum (TCRS) versus observation in infertile women with a non-recurrent miscarriage and a diagnosed uterine septum who plan to undergo IVF/ICSI. Eligible participants are women aged 20–40 meeting ASRM criteria for uterine septum who have tried to conceive for at least 12 months and are not pursuing preimplantation genetic diagnosis. The primary aim is to determine whether TCRS improves pregnancy outcomes such as live birth rate, clinical pregnancy rate, and miscarriage rate after IVF/ICSI compared with non-surgical management, while also evaluating safety. The trial is interventional, enrolling from multiple centers, and uses standard surgical techniques for septum resection with follow-up through subsequent IVF cycles.

Why it matters

Who can join: the full rules

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).

Where it's running

• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Dabao Xu
• Email: forxudabao@126.com
• Phone: 13017386201

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hysteroscopic removal of a uterine septum to help people with a septate uterus conceive naturally

  This trial will try hysteroscopic removal of the uterine septum versus expectant management to see if it increases pregnancy and live birth rates for people aged 20–40 with a septate uterus who want to get pregnant naturally and do not have recurrent miscarriage.

  Recruiting The Third Xiangya Hospital of Central South University · Changsha, Hunan · NCT07039097

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.