Table_2_Fertility Outcome and Safety of Ethiodized Poppy Seed Oil for Hysterosalpingography in 1,053 Infertile Patients: A Real-World Study.DOCX

ObjectiveEthiodized poppy seed oil for hysterosalpingography (HSG) is reported to display some therapeutic effect on infertility, but big a sample-size study under real clinical settings is still lacking to verify the speculation. Thus, this real-world study enrolled 1,053 infertile patients who underwent ethiodized poppy seed oil-based HSG to explore its fertility enhancement value.
MethodA total of 1,053 infertile patients who underwent HSG using ethiodized poppy seed oil as the contrast medium were retrospectively analyzed. The live birth rate and 3-, 6-, 12-month and total pregnancy rate were retrieved. Besides, adverse events during and after HSG were recorded.
ResultsThe 3-, 6-, 12-month and total pregnancy rate was 22, 36.8, 50, and 53.8%, respectively. The total live birth rate was 42.7%. Sub-group analyses showed that pregnancy rate was 53.7, 53.8, 54.1, and 62.4% in subgroups of primary infertility patients, secondary infertility patients, infertility patients with fallopian tube disease, and infertility patients with unknown cause, respectively. Meanwhile the live birth rate was 44.3, 41.3, 41.5, and 59.2% in these subgroups, separately. Multivariate logistic regression analysis disclosed that BMI ≥ 24 kg/m2, history of dysmenorrhea, and abnormity of sperm count or motility-related infertility were independently correlated with reduced pregnancy rate and livebirth rate (All Ps < 0.05). Adverse events mainly included pain (20.6%) and interstitial reflux (7.9%), which were mild and tolerable.
ConclusionEthiodized poppy seed oil for HSG discloses a satisfying fertility outcome with a tolerable safety profile in infertile patients; meanwhile, this effect might be influenced by BMI, history of dysmenorrhea, and paternal abnormity of sperm.

研究背景与目的：有研究表明，用于子宫输卵管造影（hysterosalpingography, HSG）的碘化罂粟籽油（ethiodized poppy seed oil）对不孕症具有一定治疗功效，但目前仍缺乏真实临床场景下的大样本研究来验证这一推测。为此，本真实世界研究纳入1053例接受碘化罂粟籽油子宫输卵管造影的不孕症患者，旨在探讨其改善生育能力的价值。
方法：本研究回顾性分析了1053例以碘化罂粟籽油为造影剂行子宫输卵管造影的不孕症患者。收集患者术后3个月、6个月、12个月妊娠率及总体妊娠率与活产率，并记录子宫输卵管造影术中及术后的不良事件。
结果：本研究中患者术后3个月、6个月、12个月及总体妊娠率分别为22%、36.8%、50%及53.8%，总体活产率为42.7%。亚组分析显示，原发性不孕症患者、继发性不孕症患者、输卵管病变相关性不孕症患者及不明原因不孕症患者的妊娠率分别为53.7%、53.8%、54.1%及62.4%，对应的活产率分别为44.3%、41.3%、41.5%及59.2%。多因素logistic回归分析显示，体质量指数（Body Mass Index, BMI）≥24 kg/m²、痛经史以及精子数量或活力异常相关性不孕症，均为妊娠率与活产率降低的独立危险因素（所有P值均<0.05）。不良事件主要为疼痛（20.6%）与间质反流（7.9%），症状均轻微且可耐受。
结论：以碘化罂粟籽油为造影剂行子宫输卵管造影，可使不孕症患者获得满意的生育结局，且安全性良好、不良事件可耐受；其生育改善效果可能受体质量指数、痛经史以及男方精子异常的影响。