Clinical trial NCT03395301: Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx
Official title: Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hydrosalpinx
Keywords: hysteroscopy
fiber platinum coil
tubal occlusion
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Platinum coils were inserted into the tubes.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate
timeFrame: 2 months after IVF-ET
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: the 1st Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: the 1st affiliated hospital of Wenzhou Medical College
name: Feng Lin, Gynecologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.