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 (RRâ¯=â¯0.66, 95% CI 0.34 to 1.32, Pâ¯=â¯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 (RRâ¯=â¯0.84, 95% CI 0.46 to 1.55, Pâ¯=â¯0.58). Ectopic pregnancy was diagnosed in two women in the HSG group (1.4%) and none in the THL group (Pâ¯=â¯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.
Subject(s)
Fallopian Tube Diseases , Fallopian Tube Patency Tests/methods , Hysterosalpingography/methods , Infertility, Female , Laparoscopy/methods , Adult , Equivalence Trials as Topic , Fallopian Tube Diseases/complications , Fallopian Tube Diseases/diagnosis , Fallopian Tube Diseases/therapy , Female , Humans , Hysteroscopy/methods , Infant, Newborn , Infertility, Female/diagnosis , Infertility, Female/etiology , Infertility, Female/therapy , Live Birth , Male , Netherlands , Pregnancy , Pregnancy Outcome , Treatment Outcome , Vagina/diagnostic imagingABSTRACT
Transvaginal hydrolaparoscopy (THL) is performed to investigate tubal pathology in subfertile women. This retrospective multicentre cohort study investigated the results of THL and subsequent pregnancy rates. Between 2000 and 2011, 1033 subfertile women participated in the study. The primary outcome measure was intrauterine pregnancy, either after natural conception or after treatment with intrauterine insemination or ovulation induction. Cumulative intrauterine pregnancy rates were calculated using Kaplan-Meier analysis and fecundity rate ratios (FRR) were established. THL showed bilateral patent tubes in 83%, one-sided tubal occlusion in 12.4% and bilateral tubal occlusion in 4.6% of women. Cumulative intrauterine pregnancy rates after 36 months were 52% for women with bilateral patent tubes, 44% for one-sided tubal occlusion (FRR 1.04; 95% confidence interval [CI], 0.78 to 1.39) and 7% for bilateral tubal occlusion (FRR 0.13; 95% CI, 0.04 to 0.43). Endometriosis was diagnosed in 6.4%, and adhesions in 9.1%, while 3.9% of women had both. Corresponding FRR were 0.73 (95% CI, 0.49 to 1.09), 0.68 (95% CI, 0.46 to 1.02) and 0.42 (95% CI, 0.20 to 0.84). In conclusion, women with bilateral tubal occlusion or a combination of endometriosis and adhesions found on THL significantly reduced chances of natural conception.
