Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
Primary Purpose
IVF-ET, Hydrosalpinx
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiological tubal blockage
laparoscopic salpingectomy
Sponsored by
About this trial
This is an interventional treatment trial for IVF-ET
Eligibility Criteria
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
Sites / Locations
- ShangHai JIAI Genetics&IVF Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the radiological tubal blockage group
the laparoscopic salpingectomy group
Arm Description
Outcomes
Primary Outcome Measures
live birth rate
the rate of live births per cycle
Secondary Outcome Measures
positive hCG level
defined with the result of serum β-hCG ≥10 mIU/mL.
clinical pregnancy rate
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
ongoing pregnancy rate
presence of a fetal pole with pulsation at 12 weeks of gestation
implantation rate
number of gestational sacs per embryo transferred
multiple pregnancy
more than one intrauterine sacs on scanning
miscarriage rate
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
ectopic pregnancy
pregnancy outside the uterine cavity
birth weight
birth weight of the baby delivered
Full Information
NCT ID
NCT03521128
First Posted
April 12, 2018
Last Updated
September 20, 2019
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
1. Study Identification
Unique Protocol Identification Number
NCT03521128
Brief Title
Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
Official Title
A Randomized Trial Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
poor recruitment, no participants enrolled
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
July 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ShangHai Ji Ai Genetics & IVF Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF-ET, Hydrosalpinx
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the radiological tubal blockage group
Arm Type
Experimental
Arm Title
the laparoscopic salpingectomy group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
radiological tubal blockage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic salpingectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
live birth rate
Description
the rate of live births per cycle
Time Frame
a live birth after 22 weeks gestation, through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
positive hCG level
Description
defined with the result of serum β-hCG ≥10 mIU/mL.
Time Frame
A blood hCG test is performed 14 days after the FET, up to 14 days
Title
clinical pregnancy rate
Description
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
Time Frame
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
Title
ongoing pregnancy rate
Description
presence of a fetal pole with pulsation at 12 weeks of gestation
Time Frame
iable pregnancy beyond gestation 12 weeks, up to 12 weeks
Title
implantation rate
Description
number of gestational sacs per embryo transferred
Time Frame
number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
Title
multiple pregnancy
Description
more than one intrauterine sacs on scanning
Time Frame
multiple pregnancy beyond gestation 12 weeks up to 12 weeks
Title
miscarriage rate
Description
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
Time Frame
a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
Title
ectopic pregnancy
Description
pregnancy outside the uterine cavity
Time Frame
ectopic pregnancy during first trimester, up to 12 weeks
Title
birth weight
Description
birth weight of the baby delivered
Time Frame
a live birth after 22 weeks gestation, through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ShangHai JIAI Genetics&IVF Institute
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
10098478
Citation
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.
Results Reference
background
PubMed Identifier
10325271
Citation
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.
Results Reference
background
PubMed Identifier
19035133
Citation
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.
Results Reference
background
PubMed Identifier
28579408
Citation
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.
Results Reference
background
PubMed Identifier
24393165
Citation
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.
Results Reference
background
PubMed Identifier
20091531
Citation
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.
Results Reference
background
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Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
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