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Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03395301
Enrollment
80
Registered
2018-01-10
Start date
2015-12-01
Completion date
2018-07-30
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrosalpinx

Keywords

hysteroscopy, fiber platinum coil, tubal occlusion

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.

Interventions

DEVICECoil

Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Platinum coils were inserted into the tubes.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pregnancy rate2 months after IVF-ETPatients will be followed up with the pregnancy outcomes after the tubal occlusion

Countries

China

Contacts

Primary ContactFeng Lin, Gynecologist
234898067@qq.com13868585597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026