Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ovulation rate
研究概览
简要总结
This randomized clinical trial aims to compare the efficacy and safety of extended letrozole therapy (5 mg/day for 10 days) versus standard letrozole therapy (5 mg/day for 5 days) for ovulation induction in women with polycystic ovary syndrome (PCOS). A total of 84 women aged 18-40 years will be randomized into two groups. Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum presence. The primary outcome is ovulation rate, while secondary outcomes include number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, number of cycles until pregnancy, and incidence of ovarian hyperstimulation syndrome (OHSS).
详细描述
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder and one of the leading causes of anovulatory infertility worldwide. Letrozole, an aromatase inhibitor, has emerged as the preferred first-line pharmacological agent for ovulation induction in women with PCOS. Despite its widespread use, there is ongoing debate regarding the optimal duration of therapy to maximize ovulatory and pregnancy outcomes.
This randomized clinical trial is designed to evaluate whether an extended regimen of letrozole provides superior reproductive outcomes compared with the standard regimen. The extended protocol consists of daily administration of 5 mg letrozole from cycle day 2 through day 12, whereas the standard regimen involves 5 mg daily from cycle day 2 through day 6. Ovulatory response will be monitored through serial transvaginal ultrasound and biochemical markers of ovulation.
The trial aims to generate high-quality evidence on the efficacy and safety of extended letrozole therapy. The findings may inform future clinical guidelines on ovulation induction strategies in women with PCOS and contribute to optimizing treatment protocols for anovulatory infertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to 40 years;
- •BMI between 18,5 and 31 kg/m2
- •Diagnosis of Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria (2003) (presence of at least two of the following: oligo/anovulation, clinical and/or biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound);
- •Active desire for pregnancy at the time of enrollment;
- •Ability and willingness to provide written informed consent (ICF).
排除标准
- •Age <18 or >40 years;
- •Presence of confirmed bilateral tubal factor, severe male factor infertility, premature ovarian insufficiency, uncontrolled hyperprolactinemia or thyroid dysfunction);
- •Congenital or acquired uterine malformations;
- •History of gynecologic or breast cancer;
- •Known hypersensitivity to, or contraindication for, letrozole;
- •Severe uncontrolled systemic disease (e.g., cardiovascular, renal, or hepatic disorders);
- •Pregnancy or breastfeeding at the time of screening.
研究组 & 干预措施
Traditional Letrozole Therapy
Participants in this group will receive standard letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg/day from cycle day 2 through cycle day 6 (5 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum visualization. This arm serves as the active comparator against the extended regimen for evaluating efficacy and safety outcomes.
干预措施: Traditional Letrozole Therapy (Drug)
Extended Letrozole Therapy
Participants in this group will receive extended letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg/day from cycle day 2 through cycle day 12 (10 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum visualization. This arm will be compared with the standard regimen to assess differences in ovulation rate, follicular development, pregnancy outcomes, and safety.
干预措施: Extended Letrozole Therapy (Drug)
结局指标
主要结局
Ovulation rate
时间窗: Assessed within one treatment cycle (up to 6 weeks from the start of medication).
Proportion of participants achieving ovulation, defined as the presence of a dominant follicle ≥18 mm on transvaginal ultrasound with confirmation by urinary LH surge and/or visualization of corpus luteum.
次要结局
- Clinical Pregnancy Rate(Assessed within 8 weeks after the start of treatment.)
- Number of Mature Follicles(Assessed during one treatment cycle (up to 6 weeks).)
- Follicular Size(Assessed during one treatment cycle (up to 6 weeks).)
- Miscarriage Rate(Assessed up to 12 weeks of gestation.)
- Multiple Pregnancy Rate(Assessed within 8 weeks after the start of treatment.)
- Incidence of Ovarian Hyperstimulation Syndrome (OHSS)(Assessed within one treatment cycle (up to 6 weeks).)
研究者
GABRIEL MONTEIRO PINHEIRO
Study Director, Obstetrician and Gynecologist, Department of Obstetrics and Gynecology, Hospital Wladimir Arruda; Professor of Obstetrics and Gynecology, University of Santo Amaro (UNISA)
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