Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
September 20, 2019 updated by: ShangHai Ji Ai Genetics & IVF Institute
A Randomized Trial Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
Hydrosalpinx (HX) has a detrimental effect on the rates of implantation, pregnancy, live delivery, and early pregnancy loss during in vitro fertilization (IVF).
The effectiveness of radiological tubal blockage has not been compared with the standard treatment of laparoscopic salpingectomy in randomized trials.
The investigators aim in this randomized trial to compare the live birth rate of radiological tubal blockage versus laparoscopic salpingectomy in infertility women with HX prior to frozen-thawed embryo transfer (FET).
Eligible women will be recruited and randomized into one of the following two groups: (1) the radiological tubal blockage group and (2) the laparoscopic salpingectomy group.
The primary outcome is the live birth rate.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- ShangHai JIAI Genetics&IVF Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 43 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged 20-43 years at the time of IVF/ICSI treatment
- Unilateral or bilateral HX visible on pelvic ultrasound or hysterosalpingogram
- At least one frozen embryo or blastocyst available for transfer
Exclusion Criteria:
- A history of pelvic inflammatory disease within 6 months
- HX that were already blocked proximally on hysterosalpingogram
- Frozen pelvis from previous laparoscopy
- Women with fibroids interfering with radiological tubal blockage
- Undergoing preimplantation genetic testing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: the radiological tubal blockage group
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In radiological tubal blockage group, under the fluoroscopy of X-ray, after confirming HX by HSG, selective catheterization will be done for the affected tube and micro spring coils will be put in to the interstitial tube and isthmus through micro catheter.
The micro spring coil will be placed into the proximal end of the Fallopian tube (unilateral or bilateral depending on whether one or two HX were present) through micro catheter under the fluoroscopy of X-ray.
Then HSG will be carried out to check the position of the micro spring coil and confirm complete blockage.
Four weeks after the radiological procedure, a HSG will be performed to recheck the position of the micro spring coil and complete blockage of the tubes.
FET is proceeded in the next menstrual cycle after HSG examination.
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ACTIVE_COMPARATOR: the laparoscopic salpingectomy group
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In the laparoscopic salpingectomy group, after confirming HX, a unilateral or bilateral salpingectomy will be performed in a standard manner, depending on whether unilateral or bilateral HX are present.
In women with extensive pelvic adhesions during laparoscopy, proximal tubal ligation will be performed as an alternative procedure to salpingectomy.
FET is proceeded in the next menstrual cycle after the laparoscopic operation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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live birth rate
Time Frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
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the rate of live births per cycle
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a live birth after 22 weeks gestation, through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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clinical pregnancy rate
Time Frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
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presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
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presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
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implantation rate
Time Frame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
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number of gestational sacs per embryo transferred
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number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
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miscarriage rate
Time Frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
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defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy.
The denominator is the clinical pregnancy.
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a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
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birth weight
Time Frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
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birth weight of the baby delivered
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a live birth after 22 weeks gestation, through study completion, an average of 1 year
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positive hCG level
Time Frame: A blood hCG test is performed 14 days after the FET, up to 14 days
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defined with the result of serum β-hCG ≥10 mIU/mL.
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A blood hCG test is performed 14 days after the FET, up to 14 days
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ongoing pregnancy rate
Time Frame: iable pregnancy beyond gestation 12 weeks, up to 12 weeks
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presence of a fetal pole with pulsation at 12 weeks of gestation
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iable pregnancy beyond gestation 12 weeks, up to 12 weeks
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multiple pregnancy
Time Frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
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more than one intrauterine sacs on scanning
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multiple pregnancy beyond gestation 12 weeks up to 12 weeks
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ectopic pregnancy
Time Frame: ectopic pregnancy during first trimester, up to 12 weeks
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pregnancy outside the uterine cavity
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ectopic pregnancy during first trimester, up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aboulghar MA, Mansour RT, Serour GI. Controversies in the modern management of hydrosalpinx. Hum Reprod Update. 1998 Nov-Dec;4(6):882-90. doi: 10.1093/humupd/4.6.882.
- Camus E, Poncelet C, Goffinet F, Wainer B, Merlet F, Nisand I, Philippe HJ. Pregnancy rates after in-vitro fertilization in cases of tubal infertility with and without hydrosalpinx: a meta-analysis of published comparative studies. Hum Reprod. 1999 May;14(5):1243-9. doi: 10.1093/humrep/14.5.1243.
- Li Q, Kuang YP, Yang HL, Fu YL, Sun H, Fan LP, Shi HB. [Application of fallopian tube embolization before in vitro fertilization and embryo transfer dealing with the hydrosalpinx]. Zhonghua Fu Chan Ke Za Zhi. 2008 Jun;43(6):414-7. Chinese.
- Xu B, Zhang Q, Zhao J, Wang Y, Xu D, Li Y. Pregnancy outcome of in vitro fertilization after Essure and laparoscopic management of hydrosalpinx: a systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):84-95.e5. doi: 10.1016/j.fertnstert.2017.05.005. Epub 2017 Jun 1.
- Arora P, Arora RS, Cahill D. Essure((R)) for management of hydrosalpinx prior to in vitro fertilisation-a systematic review and pooled analysis. BJOG. 2014 Apr;121(5):527-36. doi: 10.1111/1471-0528.12533. Epub 2014 Jan 3.
- Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 5, 2018
Primary Completion (ANTICIPATED)
May 1, 2020
Study Completion (ANTICIPATED)
July 1, 2029
Study Registration Dates
First Submitted
April 12, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (ACTUAL)
May 11, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 20, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.
Data will be available when beginning 3 months and ending 5 years following article publication.
To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way.
Proposals should be directed to lihe198900@163.com.
And data are available for 5 years at a third party website (link to be included after the article publication).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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