Bracco Imaging Receives Regulatory Approval in China for Sulphur hexafluoride (SF6) in the Assessment of Fallopian Tube Patency
New indication of SF6 microbubbles supports non-invasive assessment of female infertility through contrast-enhanced ultrasound in China.
Bracco Imaging, a global leader in diagnostic imaging, today announced that its ultrasound contrast agent has been approved by the China’s National Medical Products Administration (NMPA) for use in hysterosalpingo-contrast-sonography (HyCoSy).
HyCoSy is a contrast-enhanced ultrasound (CEUS) procedure that helps identifying potential causes of female infertility related to blockage of the fallopian tubes or uterine abnormalities with a high level of diagnostic accuracy (1,2). Fallopian tube conditions, such as blockages, scarring, or other damage, are a leading cause of infertility, contributing to approximately 25–35 percent of cases of infertility among women in China (3).
This regulatory approval represents an important milestone in the management of infertility because, unlike laparoscopic assessment of tubal patency with use of a dye, HyCoSy is a non-invasive procedure, and, unlike traditional X-ray hysterosalpingography, HyCosy does not expose to radiation the genital tract of women in their reproductive years (4-6).
1) Qu E, Zhang M, Ju J, Chen Y, Lin X, Zhang X. Is Hysterosalpingo-Contrast Sonography (HyCoSy) Using Sulfur Hexafluoride Microbubbles (SonoVue) Sufficient for the Assessment of Fallopian Tube Patency? A Systematic Review and Meta-Analysis. J Ultrasound Med 2023; 42:7-15
2) Wang T, Dong T, Nie F. Clinical applications, advances, and future directions in hysterosalpingography. Front Med 2025; 12:1537506
3) Reproductive Health Branch of Chinese Preventive Medicine Association. Chinese Expert Consensus on Holistic Management of Tubal Factor Infertility (2023 edition) [J]. Chinese Journal of Practical Gynecology and Obstetrics 2023; 39:318-324
4) Roy KK, Gajapathy SR, Rai R, Zangmo R, Das A, Singhal S. Assessment of Tubal Patency with Selective Chromopertubation at Office Hysteroscopy versus Modified Minilaparoscopy in Infertile Women. Gynecol Minim Invasive Ther 2021; 10:159-165
5) Perisinakis K, Damilakis J, Grammatikakis J, Theocharopoulos N, Gourtsoyiannis N. Radiogenic risks from hysterosalpingography. Eur Radiol 2003; 13:1522-1528
6) Sulieman A, Theodorou K, Vlychou M, Topaltzikis T, Roundas C, Fezoulidis I, Kappas C. Radiation dose optimisation and risk estimation to patients and staff during hysterosalpingography. Radiat Prot Dosimetry 2008;128:217-226