A Randomized Trial of Stair-Step Letrozole versus Traditional Letrozole for Subfertile Women with Polycystic Ovary Syndrome.

IF 0.7 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL
Nigerian Journal of Clinical Practice Pub Date : 2025-04-01 Epub Date: 2025-04-26 DOI:10.4103/njcp.njcp_516_24
S Karakaya, Y Kumtepe, R A Al, Gnc Senocak, Ept Yılmaz
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引用次数: 0

Abstract

Background: Traditional letrozole or clomiphene treatment is started on cycle days 3 to 5, following a spontaneous menses or progestin-induced bleeding. If ovulation does not occur, the dose is increased following a progestin-induced bleeding. An alternative stair step protocol has been described, and if ovulation does not occur in this protocol, a higher dose is used without inducing withdrawal bleeding. There is no randomized trial comparing the traditional and stair-step letrozole protocols yet.

Aim: To compare the efficacy of traditional and stair-step protocols for ovulation induction using letrozole in women with polycystic ovary syndrome (PCOS).

Methods: A total of 200 eligible women were given 5 mg/day letrozole, and those 80 who did not respond were randomized in a 1:1 ratio to stair-step or traditional letrozole therapy for up to 10 mg/day. For the traditional protocol, higher doses of letrozole were used in each new cycle if no ovulation occurred. For the stair-step protocol, higher doses of letrozole were given 7 days after the last dose if no dominant follicles were seen on ultrasonography. The PCOS was defined according to modified Rotterdam criteria. Participants were 18 to 35 years of age, had a body mass index of <40 kg/m2, had at least one patent fallopian tube, had a normal uterine cavity, and had normal spermiogram results.

Results: The median follicle development time was significantly longer in the traditional protocol group than in the stair-step protocol group (41 days, 95% CI (40-42) vs 25 days, 95% CI (25-26); log rank 64; P < 0.001). Between traditional and stair step groups, the cumulative ovulation ratio (37/40 [%93] vs 36/40 [%90]; P = 1), endometrial thickness (9 [5-13] vs. 9 [5-11]; P = 0.005), mature follicule development (36/40 [%90] vs 36/40 [%90]; P = 0.549), pregnancy rates (3/40 [%8] vs 2/40 [%5]; P = 1), and antiestrogenic side effects were similar.

Conclusions: The stair-step protocol shortens the treatment time without causing any detrimental effects on ovulation outcome.

阶梯来曲唑与传统来曲唑治疗多囊卵巢综合征不孕妇女的随机试验。
背景:传统的来曲唑或克罗米芬治疗在月经周期第3至5天开始,在自然月经或孕激素引起的出血之后。如果没有排卵,则在黄体酮引起出血后增加剂量。另一种阶梯治疗方案已被描述,如果在该方案中未发生排卵,则使用更高的剂量而不会引起停药出血。目前还没有比较传统来曲唑方案和阶梯来曲唑方案的随机试验。目的:比较来曲唑对多囊卵巢综合征(PCOS)妇女传统促排卵方案和阶梯促排卵方案的效果。方法:总共200名符合条件的女性给予5mg /天的来曲唑治疗,80名没有反应的女性以1:1的比例随机分配到阶梯或传统的来曲唑治疗中,剂量为10mg /天。对于传统方案,如果没有排卵,则在每个新周期中使用更高剂量的来曲唑。对于阶梯方案,如果超声检查未发现优势卵泡,则在最后一次给药后7天给予更高剂量的来曲唑。PCOS是根据修改后的鹿特丹标准定义的。结果:传统方案组的中位卵泡发育时间明显长于阶梯方案组(41天,95% CI (40-42) vs 25天,95% CI (25-26);日志等级64;P < 0.001)。传统组和阶梯组的累计排卵比分别为37/40[%93]和36/40 [%90];P = 1),子宫内膜厚度(9 [5-13]vs. 9 [5-11];P = 0.005),成熟卵泡发育(36/40 [%90]vs 36/40 [%90];P = 0.549),妊娠率(3/40 [%8]vs 2/40 [%5];P = 1),抗雌激素副作用相似。结论:阶梯式方案缩短了治疗时间,对排卵结果无不良影响。
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来源期刊
Nigerian Journal of Clinical Practice
Nigerian Journal of Clinical Practice MEDICINE, GENERAL & INTERNAL-
CiteScore
1.40
自引率
0.00%
发文量
275
审稿时长
4-8 weeks
期刊介绍: The Nigerian Journal of Clinical Practice is a Monthly peer-reviewed international journal published by the Medical and Dental Consultants’ Association of Nigeria. The journal’s full text is available online at www.njcponline.com. The journal allows free access (Open Access) to its contents and permits authors to self-archive final accepted version of the articles on any OAI-compliant institutional / subject-based repository. The journal makes a token charge for submission, processing and publication of manuscripts including color reproduction of photographs.
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