NCT03521128

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
38mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2018Jul 2029

First Submitted

Initial submission to the registry

April 12, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

May 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
9.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Expected
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

April 12, 2018

Last Update Submit

September 20, 2019

Conditions

IVF-ETHydrosalpinx

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    the rate of live births per cycle

    a live birth after 22 weeks gestation, through study completion, an average of 1 year

Secondary Outcomes (8)

  • positive hCG level

    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, up to 6 weeks

  • ongoing pregnancy rate

    iable pregnancy beyond gestation 12 weeks, up to 12 weeks

  • implantation rate

    number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks

  • multiple pregnancy

    multiple pregnancy beyond gestation 12 weeks up to 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

the radiological tubal blockage group

EXPERIMENTAL
Procedure: radiological tubal blockage

the laparoscopic salpingectomy group

ACTIVE COMPARATOR
Procedure: laparoscopic salpingectomy

Interventions

radiological tubal blockagePROCEDURE

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.

the radiological tubal blockage group
laparoscopic salpingectomyPROCEDURE

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.

the laparoscopic salpingectomy group

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Location

Related Publications (6)

  • 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.

    PMID: 10098478BACKGROUND

  • 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.

    PMID: 10325271BACKGROUND

  • 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.

    PMID: 19035133BACKGROUND

  • 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.

    PMID: 28579408BACKGROUND

  • 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.

    PMID: 24393165BACKGROUND

  • 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.

    PMID: 20091531BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 11, 2018

Study Start

May 5, 2018

Primary Completion

May 1, 2020

Study Completion (Estimated)

July 1, 2029

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP

Locations

CN(1)