HydrosalpinxNCT03395301
Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx
A study testing Coil in people with Hydrosalpinx, run by Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Hydrosalpinx
- What is being tested?
- Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 1st Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Feng Lin, MD, linfeng983023@hotmail.com
Feng Lin, MD
About this study
Official title: Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET
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.
Read the 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.
- Conditions
- Hydrosalpinx
- Being tested
- Coil
- Keywords
- hysteroscopy, fiber platinum coil, tubal occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoilDevice
Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| tubal occlusion | Experimental | Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following. Receives: Device: Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Patients will be followed up with the pregnancy outcomes after the tubal occlusion
Measured: 2 months after IVF-ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Dec 2015
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HydrosalpinxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Platinum coils were inserted into the tubes.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Lin, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Feng Lin, Gynecologist, Principal investigator, the 1st affiliated hospital of Wenzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395301
- Sponsor's protocol ID
- Platinum coils
- Status last verified
- Dec 2017
- First submitted
- 19 May 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23561020Wu 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.
PubMed 30205314
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET
- ClinicalTrials.gov ID
- NCT03395301
- Acronym / sponsor ID
- Platinum coils
- Conditions
- Hydrosalpinx
- Keywords
- hysteroscopy, fiber platinum coil, tubal occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Platinum coils were inserted into the tubes.
| Arm | Type | Receives |
|---|---|---|
| tubal occlusion | Experimental | Device: CoilFiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoilFiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy | Device | tubal occlusion |
Primary outcome
Pregnancy rate
Time frame: 2 months after IVF-ET
Patients will be followed up with the pregnancy outcomes after the tubal occlusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 23561020Matorras 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.
- Derived from this study: PubMed 30205314Wu 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.
- Individual participant dataSharing planned: No
Related trials for Hydrosalpinx
Recruiting
Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Lin, Gynecologist principal investigator
the 1st affiliated hospital of Wenzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil in people with Hydrosalpinx, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Lin, Gynecologist (13868585597, 234898067@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 2 months after IVF-ET). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395301, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.