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| Name | Class |
|---|---|
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Maternal and Child Health Hospital of Hubei Province | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical group | Experimental | Undergoing Transcervical resection of septum |
|
| Control group | No Intervention | Routine preconception counseling and observation without hysteroscopic septectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcervical resection of septum | Procedure | Transcervical resection of septum (TCRS) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | Follow-up was conducted for 12 months after the surgery or treatment course to record the IVF/ICSI reproductive outcomes within 12 months after the initiation of embryo transfer into the cycle. | within 12 months after initiating embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse outcome rate | Pregnancy rate and cumulative pregnancy rate, miscarriage rate and cumulative miscarriage rate, preterm birth rate. | within 12 months after initiating embryo transfer in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dabao Xu | Contact | 13017386201 | forxudabao@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2025 |
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| Beijing Tiantan Hospital |
| OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| Beijing Fuxing Hospital | UNKNOWN |
| Tongji Hospital | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Southwest Hospital, China | OTHER |
| The First Hospital of Jilin University | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Xijing Hospital | OTHER |
| Shandong University | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Gansu Provincial Maternal and Child Health Care Hospital | OTHER |
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|
| Jun 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2025 | Jun 18, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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