Actively Recruiting
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
Led by The Third Xiangya Hospital of Central South University · Updated on 2025-06-26
418
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
The Third Xiangya Hospital of Central South University
Lead Sponsor
O
Obstetrics & Gynecology Hospital of Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 20 to 40 years
- Diagnosed with uterine septate based on 2024 ASRM criteria using 3D color Doppler ultrasound
- May have never been pregnant, or have history of live birth, one biochemical pregnancy, or one fetal arrest
- Infertile patients who wish to conceive naturally, including those with treatable infertility factors
- Normal ovarian reserve function (AMH >1.1 ng/ml, FSH <12 U/L on 2nd to 5th day of menstruation)
- Male partner with generally normal semen
- Willing and able to sign informed consent and comply with treatment and follow-up
You will not qualify if you...
- History of recurrent miscarriage
- Intramural uterine myoma larger than 3 cm or moderate to severe intrauterine adhesions
- Uncontrolled endocrine disorders such as abnormal thyroid function or hyperprolactinemia exceeding twice the upper limit
- Uncontrolled endometrial hyperplasia, EIN, malignant lesions, acute reproductive system inflammation, or coagulation dysfunction
- Adenomyosis with uterine body larger than 50 days of pregnancy, chocolate cysts larger than 4 cm, severe dysmenorrhea, or palpable deep infiltrating endometriosis lesions larger than 1 cm
- Untreated bilateral hydrosalpinx or obstruction
- Other major organ diseases or surgical contraindications
- Participation in other clinical trials within past three months
- Conditions requiring IVF such as untreatable fallopian tube blockage or ovulation dysfunction not responsive to medication
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
D
Dabao Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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