IVF-ETNCT03521128
Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
A study testing radiological tubal blockage and laparoscopic salpingectomy in people with IVF-ET and Hydrosalpinx, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- IVF-ET, Hydrosalpinx
- What is being tested?
- radiological tubal blockage and laparoscopic salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2018to Jul 2029
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- IVF-ET, Hydrosalpinx
- Being tested
- radiological tubal blockage, laparoscopic salpingectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiological tubal blockageProcedure or surgery
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.
laparoscopic salpingectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| the radiological tubal blockage group | Experimental | Not described Receives: Procedure: radiological tubal blockage |
| the laparoscopic salpingectomy group | Active comparator | Not described Receives: Procedure: laparoscopic salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
the rate of live births per cycle
Measured: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Secondary outcomes (8)
positive hCG level
defined with the result of serum β-hCG ≥10 mIU/mL.
Measured: A blood hCG test is performed 14 days after the FET, up to 14 days
clinical pregnancy rate
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
Measured: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
ongoing pregnancy rate
presence of a fetal pole with pulsation at 12 weeks of gestation
Measured: iable pregnancy beyond gestation 12 weeks, up to 12 weeks
implantation rate
number of gestational sacs per embryo transferred
Measured: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
multiple pregnancy
more than one intrauterine sacs on scanning
Measured: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
miscarriage rate
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
Measured: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
ectopic pregnancy
pregnancy outside the uterine cavity
Measured: ectopic pregnancy during first trimester, up to 12 weeks
birth weight
birth weight of the baby delivered
Measured: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start5 May 2018
- Primary completionMay 2020 (estimated)
- Study completionJul 2029 (estimated)
Why it stopped: poor recruitment, no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for IVF-ETStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521128
- Sponsor's protocol ID
- 2018-04
- Status last verified
- Sep 2019
- First submitted
- 12 Apr 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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.
PubMed 10098478Camus 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.
PubMed 10325271Li 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.
PubMed 19035133Xu 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.
PubMed 28579408Arora 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.
PubMed 24393165Johnson 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.
PubMed 20091531
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT03521128
- Acronym / sponsor ID
- 2018-04
- Conditions
- IVF-ET, Hydrosalpinx
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor recruitment, no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 11 May 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the radiological tubal blockage group | Experimental | Procedure: radiological tubal blockage |
| the laparoscopic salpingectomy group | Active comparator | Procedure: laparoscopic salpingectomy |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| radiological tubal blockageIn 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. | Procedure or surgery | the radiological tubal blockage group |
| laparoscopic salpingectomyIn 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. | Procedure or surgery | the laparoscopic salpingectomy group |
Primary outcome
live birth rate
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
the rate of live births per cycle
8 secondary outcomes
positive hCG level
Time frame: A blood hCG test is performed 14 days after the FET, up to 14 days
clinical pregnancy rate
Time frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
ongoing pregnancy rate
Time frame: iable pregnancy beyond gestation 12 weeks, up to 12 weeks
implantation rate
Time frame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
multiple pregnancy
Time frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
miscarriage rate
Time frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
ectopic pregnancy
Time frame: ectopic pregnancy during first trimester, up to 12 weeks
birth weight
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 10098478Aboulghar 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.
- Background: PubMed 10325271Camus 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.
- Background: PubMed 19035133Li 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.
- Background: PubMed 28579408Xu 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.
- Background: PubMed 24393165Arora 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.
- Background: PubMed 20091531Johnson 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.
- Individual participant dataSharing planned: Yes. 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).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiological tubal blockage and laparoscopic salpingectomy in people with IVF-ET and Hydrosalpinx, run by ShangHai Ji Ai Genetics & IVF Institute 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Sep 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year). 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 NCT03521128, which also lists 6 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 24 Sep 2019.