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| Name | Class |
|---|---|
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
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This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. The research attempts to answer: for infertile women with uterine septum planning to undergo IVF/ICSI (excluding preimplantation genetic diagnosis), does TCRS improve pregnancy outcomes (such as live birth rate, pregnancy rate, miscarriage rate, etc.) compared to non-surgical treatment (conservative observation), and to clarify the clinical value and safety of this surgical intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical group | Experimental | Undergoing hysteroscopic septectomy |
|
| 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 | Hysteroscopic surgery 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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| Maternal and Child Health Hospital of Hubei Province |
| OTHER |
| The First People's Hospital of Yunnan | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Gansu Maternal and Child Health Hospital | UNKNOWN |
| Shandong University | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| The First Hospital of Jilin University | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Tongji Hospital | OTHER |
| Xijing Hospital | OTHER |
| Southwest Hospital, China | OTHER |
| Beijing Fuxing Hospital | UNKNOWN |
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|
| May 20, 2026 |
| Prot_SAP_000.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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