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.
Original language | English |
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Pages (from-to) | 239-245 |
Number of pages | 7 |
Journal | Reproductive Biomedicine Online |
Volume | 43 |
Issue number | 2 |
DOIs | |
Publication status | Published - Aug 2021 |
Keywords
- 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
- PROGNOSTIC CAPACITY
- Tubal pathology
- INFERTILITY
- LAPAROSCOPY
- Hysterosalpingography
- ACCURACY
- Transvaginal hydrolaparoscopy
- Tubal testing
- Transvaginal endoscopy