Clinical trial NCT03521128: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: IVF-ET
Hydrosalpinx
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: live birth rate
timeFrame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Secondary outcomes:
measure: positive hCG level
timeFrame: A blood hCG test is performed 14 days after the FET, up to 14 days
measure: clinical pregnancy rate
timeFrame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
measure: ongoing pregnancy rate
timeFrame: iable pregnancy beyond gestation 12 weeks, up to 12 weeks
measure: implantation rate
timeFrame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
measure: multiple pregnancy
timeFrame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
measure: miscarriage rate
timeFrame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
measure: ectopic pregnancy
timeFrame: ectopic pregnancy during first trimester, up to 12 weeks
measure: birth weight
timeFrame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShangHai JIAI Genetics&IVF Institute
Study officials:
References:
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.
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.
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.
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.
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.
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.