Success rate of letrozole vs clomiphene citrate as pregnancy inducers in infertile Sudanese patients with polycystic ovary syndrome

Polycystic ovary syndrome (PCOS) -associated with infertility- is becoming very common among Sudanese patients. Despite the wide acceptance of clomiphene citrate as the first-line drug for ovulation induction, a significant proportion of women do not respond to the treatment. On the other hand, the AIs were increasingly been used as single high doses although the teratogenic effects and safety on fetal development were still debatable. General objective To compare letrozole vs clomiphene citrate success rate as pregnancy inducers in the treatment of infertile Sudanese patients with PCOS and to assess the side effects from the two drugs. Specific objective To assess letrozole vs clomiphene citrate activity in the treatment of infertility in Sudanese patients with PCOS by comparing the effects of the two drugs on the: • Different doses used to induce conception • Maturation of follicles to sizes ≥18 mm • Change in the ovarian cyst sizes • Change in the endometrial thickness • Achieved positive pregnancy tests outcome after induction • Assess the incidence of side effects from the two drugs 2. Methods 2.1: Study design This research is designed as a retrospective, cross-sectional study to evaluate letrazole vs CC success rates as pregnancy inducers in infertile Sudanese patients with PCOS. One hundred patient files from 3 infertility centers at Khartoum City were enrolled covering the December 2015-December 2020 were enrolled with half the patients on letrazole and the other half on CC. The number of detected mature follicles ≥18mm and positive pregnancy test outcomes after induction were used for assessment. Side effects were assessed as reported on files. Significance was measured with a T-test using SPSS version 23 and P≤0.05 was considered significant. Association between variables was assessed with logistic regression.多囊卵巢综合征（Polycystic ovary syndrome, PCOS）与不孕症相关，在苏丹患者中发病率日益升高。尽管枸橼酸氯米芬（clomiphene citrate）作为促排卵一线药物已被广泛接受，但仍有相当比例的女性对该治疗无应答。另一方面，尽管芳香化酶抑制剂（AIs）的致畸效应及对胎儿发育的安全性仍存在争议，但其高剂量单药使用的情况正日益增多。 研究总目标 比较来曲唑（letrozole）与枸橼酸氯米芬作为促孕药物，治疗苏丹多囊卵巢综合征不孕症患者的临床成功率，并评估两种药物的不良反应。 具体研究目标 通过对比两种药物对以下指标的影响，评估来曲唑与枸橼酸氯米芬治疗苏丹多囊卵巢综合征不孕症患者的疗效： • 用于诱导受孕的不同给药剂量 • 卵泡发育至直径≥18mm的成熟情况 • 卵巢囊肿体积的变化 • 子宫内膜厚度的变化 • 诱导治疗后妊娠试验阳性的结局 • 评估两种药物的不良反应发生率 2. 方法 2.1 研究设计 本研究为回顾性横断面研究，旨在评估来曲唑与枸橼酸氯米芬治疗苏丹多囊卵巢综合征不孕症患者的促孕成功率。研究纳入2015年12月至2020年12月间喀土穆市3家不孕症中心的100份患者病历，其中半数患者接受来曲唑治疗，另一半接受枸橼酸氯米芬治疗。以诱导治疗后检测到的直径≥18mm的成熟卵泡数量及妊娠试验阳性结局作为核心评估指标；不良反应则依据病历中的记录进行评估。统计学分析采用SPSS 23版本进行t检验，以P≤0.05作为差异具有统计学意义的判定标准；变量间的关联分析采用逻辑回归分析。