An interventional study of radiological tubal blockage and laparoscopic salpingectomy in IVF-ET and Hydrosalpinx, sponsored by ShangHai Ji Ai Genetics & IVF Institute. Withdrawn at 1 site in China. Open to female participants aged 20 Years to 43 Years. Per ClinicalTrials.gov, last updated 2019-09-24.
Sponsored by ShangHai Ji Ai Genetics & IVF Institute · Not applicable, Interventional, and 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.
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Exclusion Criteria:
Procedure: radiological tubal blockage
Procedure: laparoscopic salpingectomy
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.
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.
live birth rate
the rate of live births per cycle
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
positive hCG level
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
clinical pregnancy rate
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
ongoing pregnancy rate
presence of a fetal pole with pulsation at 12 weeks of gestation
Time frame: iable pregnancy beyond gestation 12 weeks, up to 12 weeks
implantation rate
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
multiple pregnancy
more than one intrauterine sacs on scanning
Time frame: 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.
Time frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
ectopic pregnancy
pregnancy outside the uterine cavity
Time frame: ectopic pregnancy during first trimester, up to 12 weeks
birth weight
birth weight of the baby delivered
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Plan to share: 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).
Supporting information: Study protocol, Sap
This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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ShangHai Ji Ai Genetics & IVF Institute