Hysteroscopic removal of a uterine septum to help people with a septate uterus conceive naturally
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 418 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07039097 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, randomized controlled study comparing transcervical resection of septum (TCRS) to expectant management in patients with a septate uterus who plan natural conception. Eligible participants are 20–40 years old, meet ASRM criteria for a septate uterus, have normal ovarian reserve and generally normal semen parameters, and may include infertile patients whose other factors can be treated. The trial allows treatment of other correctable infertility issues in both groups while following natural conception attempts. Main outcomes include pregnancy rate, live birth rate, and pregnancy outcomes after TCRS versus expectant care.
Who should consider this trial
Good fit: Ideal candidates are people aged 20–40 with a septate uterus by 3D ultrasound, normal ovarian reserve and generally normal partner semen, who wish to attempt natural conception and may have only one prior loss or treatable infertility factors.
Not a fit: Patients older than 40, those with diminished ovarian reserve, recurrent miscarriage, severe male-factor infertility, or those planning immediate assisted reproduction (IVF) may be unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could increase the chances of pregnancy and live birth for people with a septate uterus who are trying to conceive naturally.
How similar studies have performed: Previous studies—mainly in patients with recurrent miscarriage—have suggested benefit from septum resection but the evidence is mixed and high-quality randomized data in patients without recurrent losses remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.).
Where this trial is running
Changsha, Hunan
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Dabao Xu
- Email: forxudabao@126.com
- Phone: 13017386201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.