Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET

Conditions
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Hydrosalpinx

Intervention / Treatment
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* Device: Coil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have unilateral or bilateral hydrosalpinxs as evidenced by HSG. laparoscopic surgery was considered to be contraindicated because of ex-tensive pelvic adhesions. Are willing to undergo a hysterosalpingogram (HSG) 1 months after fiber platinum coil placement to confirm proximal tubal occlusion. Are willing to participate in this clinical study .Are able to comprehend and give informed consent for participation in this study. Have read, understood and signed an informed consent form . Exclusion Criteria: Active or recent upper or lower pelvic infection Known hypersensitivity to nickel as confirmed by skin test Known allergy to contrast media Pregnancy or suspected pregnancy Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum Poor general or gynecologic health Inability or refusal to provide informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Platinum coils were inserted into the tubes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tubal occlusion<br>Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following. | Device: Coil<br>* Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Patients will be followed up with the pregnancy outcomes after the tubal occlusion | 2 months after IVF-ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopy, fiber platinum coil, tubal occlusion