Transvaginal hydrolaparoscopy versus hysterosalpingography in the work-up for subfertility: a randomized controlled trial
Date
2021
Authors
van Kessel, M.A.
Tros, R.
van Kuijk, S.M.J.
Oosterhuis, G.J.E.
Kuchenbecker, W.K.H.
Bongers, M.Y.
Mol, B.W.J.
Koks, C.A.M.
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Journal article
Citation
Reproductive BioMedicine Online, 2021; 43(2):239-245
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Mianne van Kessel, Rachel Tros, Sander van Kuijk, Jur Oosterhuis, Walter Kuchenbecker, Marlies Bongers, Ben Willem Mol, Carolien Koks
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Abstract
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.
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© 2021 Published by Elsevier Ltd on behalf of Reproductive Healthcare Ltd.