Transvaginal hydrolaparoscopy versus hysterosalpingography in the work-up for subfertility: a randomized controlled trial

Mianne van Kessel*, Rachel Tros, Sander van Kuijk, Jur Oosterhuis, Walter Kuchenbecker, Marlies Bongers, Ben Willem Mol, Carolien Koks

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Web of Science)


RESEARCH QUESTION: Is transvaginal hydrolaparoscopy (THL) non-inferior to hysterosalpingography (HSG) as a first-line tubal patency test in subfertile women in predicting the chance of conception leading to live birth?

DESIGN: A multicentre, randomized controlled trial in four teaching hospitals in the Netherlands, which randomized subfertile women scheduled for tubal patency testing to either THL or HSG as a first-line tubal patency test. The primary outcome was conception leading to live birth within 24 months after randomization.

RESULTS: A total of 149 women were randomized to THL and 151 to HSG. From the intention-to-treat population, 83 women from the THL group (58.5%) conceived and delivered a live born child within 24 months after randomization compared with 82 women (55.4%) in the HSG group (difference 3.0%, 95% CI -8.3 to 14.4). Time to conception leading to live birth was not statistically different between groups. Miscarriage occurred in 16 (11.3%) women in the THL group, versus 20 (13.5%) women in the HSG group (RR = 0.66, 95% CI 0.34 to 1.32, P = 0.237), and multiple pregnancies occurred in 12 (8.4%) women in the THL group compared with 19 (12.8%) women in the HSG group (RR = 0.84, 95% CI 0.46 to 1.55, P = 0.58). Ectopic pregnancy was diagnosed in two women in the HSG group (1.4%) and none in the THL group (P = 0.499).

CONCLUSION: In a preselected group of subfertile women with a low risk of tubal pathology, use of THL was not inferior to HSG as a first-line test for predicting conception leading to live birth.

Original languageEnglish
Pages (from-to)239-245
Number of pages7
JournalReproductive Biomedicine Online
Issue number2
Publication statusPublished - Aug 2021


  • Adult
  • Equivalence Trials as Topic
  • Fallopian Tube Diseases/complications
  • Fallopian Tube Patency Tests/methods
  • Female
  • Humans
  • Hysterosalpingography/methods
  • Hysteroscopy/methods
  • Infant, Newborn
  • Infertility, Female/diagnosis
  • Laparoscopy/methods
  • Live Birth
  • Male
  • Netherlands
  • Pregnancy
  • Pregnancy Outcome
  • Treatment Outcome
  • Vagina/diagnostic imaging
  • TVE
  • Tubal pathology
  • Hysterosalpingography
  • Transvaginal hydrolaparoscopy
  • Tubal testing
  • Transvaginal endoscopy

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