Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2018-07-30

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.

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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.

Conditions

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Hydrosalpinx

Study Design

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Intervention Model

SEQUENTIAL

Platinum coils were inserted into the tubes.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tubal occlusion

Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following.

Group Type EXPERIMENTAL

Coil

Intervention Type DEVICE

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

Interventions

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Coil

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No