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临床试验/NCT01577017
NCT01577017已完成3 期

Study On The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)

Nik Hazlina0 个研究点目标入组 150 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
150
主要终点
To evaluate the effectiveness of ovulation induction among PCOS patients

研究概览

简要总结

As both medications i.e. CC and letrozole have been shown to be effective in inducing ovulation in PCOS patients, this study was performed in order to evaluate which regime (whether CC or letrozole) is the best to be used as the first line treatment for PCOS patients with infertility for local population. The best regime will therefore could be included in the protocol of management of infertility patients with PCOS so that the quality of patients' care could be improved.

详细描述

Polycystic Ovarian Syndrome (PCOS) is the most common endocrinopathy among women of reproductive age group and is one of the leading causes of infertility. It is characterized by chronic anovulation and hyperandrogenism with variable clinical manifestations that include oligomenorrhea, infertility, hirsutism, and acne (Ehrmann DA 2005).

Several methods have been described to induce ovulation in PCOS patients- weight reduction, laparoscopic ovarian drilling and the use of various induction ovulation agents like clomiphene citrate (CC), aromatase inhibitors (AIs) and gonadotrophins.

Clomiphene citrate (CC) has been most widely used and standard drug for the treatment of infertility. It is known that clomiphene citrate results in an ovulation rate of 60-85%, but a conception rate of only around 20% (Bayar et al 2006, Sohrabvand et al 2006). About 20-25% of women are resistant to CC and do not ovulate. Discrepancy between ovulation and pregnancy rate is related to anti-estrogenic activity on endometrium and cervical mucus is due to CC has a long half life of 5 to 7 days.

In view of disappointing result of CC treatment with many adverse effect and cost and possible complication of gonadotrophin, the concept of aromatase inhibition was proposed as a new method of ovulation that are easy to use, less expensive and more effective drugs.

Letrozole is an oral, potent, reversible, and highly selective aromatase inhobitor that prevent androgen-to-estrogen (E) conversion. These aromatase inhibitors have a short half life (45 hours), hence is rapidly eliminated from the body. No adverse effect on E target tissues is seen with letrozole due to this short half life; furthermore, it does not down regulate the ER compare to CC.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Letrozole

Experimental

Group L will be assigned with Letrozole 5 mg on night on day 5 to day 9 of the cycle

干预措施: Letrozole (Drug)

结局指标

主要结局

To evaluate the effectiveness of ovulation induction among PCOS patients

时间窗: 6 weeks

To evaluate the effectiveness of letrozole and clomiphene citrate for induction of ovulation in PCOS patients.

次要结局

  • Number of patients that can ovulate and pregnant(6 weeks)

研究者

发起方
Nik Hazlina
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nik Hazlina

Associate Professor Dr

Universiti Sains Malaysia

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