PDF(Pubmed)
Abstract：
BACKGROUND: Both sildenafil and estradiol are seen to improve endometrial thickness in patients with infertility who are undergoing clomiphene induction cycles. However, the correlation between endometrial thickness and pregnancy rate is debatable. This study investigated the effect of adding oral sildenafil to clomiphene citrate (CC), compared to adding estradiol valerate, on the uterine biophysical profile (Applebaum score) and pregnancy rate.
METHODS: This was a double-blinded, randomized controlled trial conducted in Kisangani in the Democratic Republic of the Congo from October 1, 2021, to October 31, 2023. Patients with unexplained infertility were randomly assigned to one of two groups: the interventional, which was given CC (2 x 50 mg/day from day 3 to day 7 of the menstrual cycle) + sildenafil (2 x 25 mg/day orally from day 8 to day 12) or (ii) the control group, which was given CC (similar dosage as the intervention group) + EV (2 x 2 mg/day orally from day 8 to day 12), for a maximum of three cycles. Applebaum scores and clinical pregnancy rates were measured.
RESULTS: Patients in the sildenafil and EV groups were similar in mean age (29.04 versus 28.89 years). Of the 74 patients enrolled in each group, 71 in the sildenafil group and 72 in the EV group received treatment and were followed to completion. The Applebaum scores were significantly higher in the sildenafil group than in the EV group (17.05 versus 15.14, respectively, P=0.000). In the sildenafil group, the clinical pregnancy rate was also significantly higher, at 28.92% versus 20.83% in the EV group (P = 0.04).
CONCLUSIONS: As compared to EV, the oral addition of sildenafil to CC is associated with a good Applebaum score and a high rate of clinical pregnancy in patients with unexplained infertility.
METHODS: This was a double-blinded, randomized controlled trial conducted in Kisangani in the Democratic Republic of the Congo from October 1, 2021, to October 31, 2023. Patients with unexplained infertility were randomly assigned to one of two groups: the interventional, which was given CC (2 x 50 mg/day from day 3 to day 7 of the menstrual cycle) + sildenafil (2 x 25 mg/day orally from day 8 to day 12) or (ii) the control group, which was given CC (similar dosage as the intervention group) + EV (2 x 2 mg/day orally from day 8 to day 12), for a maximum of three cycles. Applebaum scores and clinical pregnancy rates were measured.
RESULTS: Patients in the sildenafil and EV groups were similar in mean age (29.04 versus 28.89 years). Of the 74 patients enrolled in each group, 71 in the sildenafil group and 72 in the EV group received treatment and were followed to completion. The Applebaum scores were significantly higher in the sildenafil group than in the EV group (17.05 versus 15.14, respectively, P=0.000). In the sildenafil group, the clinical pregnancy rate was also significantly higher, at 28.92% versus 20.83% in the EV group (P = 0.04).
CONCLUSIONS: As compared to EV, the oral addition of sildenafil to CC is associated with a good Applebaum score and a high rate of clinical pregnancy in patients with unexplained infertility.
摘要：
背景：西地那非和雌二醇均可改善接受克罗米芬诱导周期的不孕症患者的子宫内膜厚度。然而,子宫内膜厚度与妊娠率之间的相关性尚有争议。这项研究调查了口服西地那非对柠檬酸克罗米芬（CC）的影响，与添加戊酸雌二醇相比，子宫生物物理特征（Applebaum评分）和妊娠率。
方法：这是一个双盲，2021年10月1日至2023年10月31日在刚果民主共和国基桑加尼进行的随机对照试验.无法解释的不孕症患者被随机分为两组：介入治疗，给予CC（从月经周期的第3天到第7天2x50mg/天）+西地那非（从第8天到第12天口服2x25mg/天）或（ii）对照组，给予CC（与干预组相似的剂量）+EV（从第8天至第12天口服2x2mg/天），最多三个周期。测量Applebaum评分和临床妊娠率。
结果：西地那非组和EV组患者的平均年龄相似（29.04对28.89岁）。在每组的74名患者中，西地那非组71例和EV组72例接受治疗并随访至完成。西地那非组的Applebaum评分明显高于EV组（分别为17.05和15.14，P=0.000)。在西地那非组中,临床妊娠率也明显较高,EV组为28.92%对20.83%（P=0.04）。
结论：与EV相比，对于原因不明的不孕症患者,在CC中口服西地那非与良好的Applebaum评分和较高的临床妊娠率相关.
方法：这是一个双盲，2021年10月1日至2023年10月31日在刚果民主共和国基桑加尼进行的随机对照试验.无法解释的不孕症患者被随机分为两组：介入治疗，给予CC（从月经周期的第3天到第7天2x50mg/天）+西地那非（从第8天到第12天口服2x25mg/天）或（ii）对照组，给予CC（与干预组相似的剂量）+EV（从第8天至第12天口服2x2mg/天），最多三个周期。测量Applebaum评分和临床妊娠率。
结果：西地那非组和EV组患者的平均年龄相似（29.04对28.89岁）。在每组的74名患者中，西地那非组71例和EV组72例接受治疗并随访至完成。西地那非组的Applebaum评分明显高于EV组（分别为17.05和15.14，P=0.000)。在西地那非组中,临床妊娠率也明显较高,EV组为28.92%对20.83%（P=0.04）。
结论：与EV相比，对于原因不明的不孕症患者,在CC中口服西地那非与良好的Applebaum评分和较高的临床妊娠率相关.
