Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment

S

ShangHai Ji Ai Genetics & IVF Institute

Status

Withdrawn

Conditions

Hydrosalpinx
IVF-ET

Treatments

Procedure: laparoscopic salpingectomy
Procedure: radiological tubal blockage

Study type

Interventional

Funder types

Other

Identifiers

NCT03521128
2018-04

Details and patient eligibility

About

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.

Sex

Female

Ages

20 to 43 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

the radiological tubal blockage group
Experimental group
Treatment:
Procedure: radiological tubal blockage
the laparoscopic salpingectomy group
Active Comparator group
Treatment:
Procedure: laparoscopic salpingectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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