O-197 Oil-based versus water-based contrast media for hysterosalpingography in infertile women with advanced age, ovulation disorders or high risk of tubal pathology: a randomised controlled trial

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Abstract Study question Does oil-based contrast hysterosalpingography lead to higher pregnancy rates compared to water-based contrast hysterosalpingography in infertile women with age or ovarian or tubal contributory factors? Summary answer In infertile women with age or ovarian or tubal contributory factors, hysterosalpingography with oil-based or water-based contrast did not result in different ongoing pregnancy rates. What is known already The H2Oil study demonstrated that in women with unexplained infertility, tubal flushing during hysterosalpingography (HSG) with oil-based contrast (OBCM) resulted in more ongoing pregnancies than HSG with water-based contrast (WBCM) (39.7% vs 29.1%; rate ratio 1.37; 95% confidence interval [CI], 1.16 to 1.61) (Dreyer at al., 2017). This fertility enhancing effect has been confirmed in a regular meta-analysis, a network meta-analysis and a recent Cochrane review. However, to date, evidence regarding the potential fertility enhancing effect of HSG with OBCM in women aged over 39 years, or with ovulation disorders or at high risk for tubal pathology is lacking. Study design, size, duration The H2Oil2 study is an international, multicentre, randomised controlled trial, which took place in the Netherlands, China and the UK between July 2019 and December 2024. In total, 11 hospitals participated in this study. Participants/materials, setting, methods We studied infertile women, aged above 39 years and/or with ovulation disorders and/or at high risk for tubal pathology undergoing HSG during fertility work-up. Participants were randomly allocated to HSG with OBCM or WBCM. The follow-up period was six months and primary endpoint was conception leading to live birth. Since all data on live births is not yet available, this abstract reports on ongoing pregnancy rates. Outcomes were analysed according to the intention-to-treat principle. Main results and the role of chance Between August 2019 and June 2024, we randomised 932 patients (of which 490 in the Netherlands, 353 in China and 72 in the UK), of whom 459 were allocated to OBCM and 456 to WBCM. Median age was 33.4 (interquartile range [IQR]:30.0-37.8) years, median duration of infertility was 21.0 (IQR:16.0, 30.0) months and 46.8% (n = 427) of the women had primary infertility. Baseline characteristics were comparable between the groups. HSG showed bilateral tubal pathology in 48 (10.5%) of the women randomised for OBCM versus 53 (11.6%) of the women randomised for WBCM. Ongoing pregnancy rates in the first six months following randomisation were 24.2% in the intervention (OBCM) versus 21.5% in the control group (WBCM) (RR:1.13, 95% CI: 0.89-1.43). Similar non-significant findings were observed when comparing HSG with OBCM to WBCM. across the three subgroups: women of advanced age (≥39 years) (10.6% vs. 9.8%; RR: 1.08, 95% CI: 0.54–2.15), women with oligo- or anovulation (32.7% vs. 29.7%; RR: 1.10, 95% CI: 0.78-1.55), and women at high risk for tubal pathology (23.5% vs. 21.0%; RR: 1.12, 95% CI: 0.81–1.55). Limitations, reasons for caution Presented results are based on ongoing pregnancy, as some participants are still pregnant. Complete follow-up on live birth rates will be available at the ESHRE 2025 meeting. Wider implications of the findings This RCT shows that for women of advanced age, with ovulation disorders, or at high risk for tubal pathology, tubal flushing with OBCM does not increase pregnancy rates compared to tubal flushing with WBCM. HSG with OBCM as a therapeutic procedure should only be offered to women with unexplained subfertility. Trial registration number Yes

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