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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

RecruitingNAAges 20 Years - 40 YearsFemaleThe Third Xiangya Hospital of Central South Univeโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.).
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What it tests

  • Transcervical resection of septum
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Where

1 site
The Third Xiangya Hospital of Central South University
Changsha, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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