Ethiodized poppyseed oil-based contrast medium is superior to water-based contrast medium during hysterosalpingography regarding image quality improvement and fertility enhancement: A multicentric, randomized and controlled trial

Jing Zhang, Weishun Lan, Yitang Wang, Kunshan Chen, Guofu Zhang, Wenzhong Yang, Huichun Chen, Wenjian Xu, Jianxin Ma, Wenhua Qin, Yao Zhang, Wuquan Wang, Huichun Wang, Zijun Dong, Yanli Wang, Yi Chen, Ning Gang, Yichuan Tang, Jing Zhang, Weishun Lan, Yitang Wang, Kunshan Chen, Guofu Zhang, Wenzhong Yang, Huichun Chen, Wenjian Xu, Jianxin Ma, Wenhua Qin, Yao Zhang, Wuquan Wang, Huichun Wang, Zijun Dong, Yanli Wang, Yi Chen, Ning Gang, Yichuan Tang

Abstract

Background: The efficacy of ethiodized poppyseed oil in hysterosalpingography (HSG) image quality and fertility enhancement has been revealed, but whether this HSG modality has similar effects in the Chinese population is still unclear.

Methods: Between July 18, 2017, and December 29, 2019, this multicentric, randomized, two-arm, clinical trial was performed involving 15 medical centers. Infertile women meeting HSG indications were randomly assigned to an oil group and a water group. The coprimary outcome included HSG image quality during HSG and fertility-enhancing effects of HSG. This study was registered on ClinicalTrials.gov (NCT03370575).

Findings: A total of 1026 subjects were randomly assigned to an oil group (N = 508) and a water group (N = 518). HSG image quality revealed that the oil group had outstanding visualization (all P < 0.001); total image quality scores for uterus opacification or uterine outline (2.9 ± 0.4 vs. 2.7 ± 0.5), fallopian tube outline (2.3 ± 0.8 vs. 1.7 ± 0.7), fimbrial rugae (1.7 ± 1.0 vs. 1.3 ± 0.8), fallopian tube spillage (2.1 ± 0.9 vs. 1.6 ± 0.8), peritoneal distribution (2.6 ± 0.9 vs. 2.1 ± 1.0) and diagnostic quality (11.6 ± 3.4 vs. 9.5 ± 3.1) (all P < 0.001) were higher in the oil group than in the water group. Regarding fertility-enhancing evaluation, the oil group showed an increased cumulative on-going pregnancy rate, on-going pregnancy within 6 months (29.1% vs. 20.1%), clinical pregnancy (39.5% vs. 29.1%) and live birth ≥ 24 weeks of gestation (36.1% vs. 27.7%) but a shorter time to pregnancy than the water group (all P < 0.01). Concerning adverse events, the oil group showed a lower occurrence rate of abdominal pain and vaginal bleeding after HSG (both P < 0.01).

Interpretation: Ethiodized poppyseed oil-based contrast is superior to water-based contrast during HSG in terms of image quality improvement and fertility enhancement. This study indicates the priority of the application of ethiodized poppyseed oil-based contrast during the HSG procedure in infertile patients.

Funding: No funding was received.

Keywords: Ethiodized poppyseed oil-based contrast medium; Fertility enhancement; Hysterosalpingography; Image quality; Safety.

Conflict of interest statement

All other authors declare no competing interests.

© 2022 The Authors.

Figures

Figure 1
Figure 1
Study flow. Participants were randomized assigned to oil group and water group. Patients who lost to follow-up and lacking image were excluded from the image quality and safety assessment; patients who retrieved the consent form were also excluded from the fertility-enhancing assessment. HSG: hysterosalpingography.
Figure 2
Figure 2
Comparison of image quality scores between the oil group and the water group. The comparison between two groups was performed by independent t-test. Image quality scores for uterus opacification or uterine outline, fallopian tube outline, fimbrial rugae, fallopian tube spillage, peritoneal distribution, and diagnostic quality were higher in the oil group than in the water group.
Figure 3
Figure 3
Comparison of fertility-enhancing evaluations between the oil group and the water group. The comparison between two groups was performed by log-rank test. The oil group showed an increased cumulative on-going pregnancy rate than in the water group.

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