Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

Not Applicable

• Conditions: Hydrosalpinx
• Interventions: Device: Coil

• Registration Number: NCT03395301
• Lead Sponsor: Wenzhou Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2016-05-19
• Status Verified: 2017-12
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-10
• Last Update Posted: 2018-01-10
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Have unilateral or bilateral hydrosalpinxs as evidenced by HSG.
2. laparoscopic surgery was considered to be contraindicated because of ex-tensive pelvic adhesions.
3. Are willing to undergo a hysterosalpingogram (HSG) 1 months after fiber platinum coil placement to confirm proximal tubal occlusion.
4. Are willing to participate in this clinical study .Are able to comprehend and give informed consent for participation in this study.
5. Have read, understood and signed an informed consent form .

Exclusion Criteria

1. Active or recent upper or lower pelvic infection
2. Known hypersensitivity to nickel as confirmed by skin test
3. Known allergy to contrast media Pregnancy or suspected pregnancy
4. Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
5. Poor general or gynecologic health
6. Inability or refusal to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
tubal occlusion	Coil	Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	2 months after IVF-ET	Patients will be followed up with the pregnancy outcomes after the tubal occlusion

Trial Locations

Locations (1)

the 1st Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China