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this study is to investigate the success rate of proximal tubal occlusion with coil devices in women with hydrosalinx and to observe there pregnancy rate with IVF-ET.
In this study, investigators will recruit 80 females with unilateral or bilateral hydrosalpinx as confirmed by HSG. Tubal ligation may be a safe and effective method in the treatment of hydrosalpinx. But in this study, investigators will use fiber platinum coils to occlude the tubes. After the treatment, IVF-ET will be applied,and then the patients' pregnancy rate will be assessed in the following-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tubal occlusion | Experimental | Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coil | Device | Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Patients will be followed up with the pregnancy outcomes after the tubal occlusion | 2 months after IVF-ET |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Lin, Gynecologist | Contact | 13868585597 | 234898067@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Lin, Gynecologist | the 1st affiliated hospital of Wenzhou Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the 1st Affiliated Hospital of Wenzhou Medical College | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23561020 | Background | Matorras R, Rabanal A, Prieto B, Diez S, Brouard I, Mendoza R, Exposito A. Hysteroscopic hydrosalpinx occlusion with Essure device in IVF patients when salpingectomy or laparoscopy is contraindicated. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(1):54-9. doi: 10.1016/j.ejogrb.2013.02.008. Epub 2013 Apr 2. | |
| 30205314 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2015 | Dec 24, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2015 | Dec 24, 2017 | SAP_001.pdf |
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Platinum coils were inserted into the tubes.
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| Wu YC, Huang XF, Yang HY, Chen X, Wang PY, Hu Y, Lin F. Fibered platinum coil: A novel option for the patients of hydrosalpinx with laparoscopic contradiction. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:179-184. doi: 10.1016/j.ejogrb.2018.08.579. Epub 2018 Aug 27. |