Combined Letrozole and Clomid in Polycystic Ovary Syndrome: a Randomized Control Trial of Combination of Letrozole and Clomiphene Citrate or Letrozole Alone for the Treatment of Infertility in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level
研究概览
简要总结
This study evaluates the addition of clomid to letrozole for the treatment of infertility in women with polycystic ovary syndrome. Half of the participants will receive letrozole and clomid in combination, while the other half will receive letrozole alone.
详细描述
Letrozole and Clomid are both used for ovulation induction, but they have different mechanisms of action. Letrozole has been shown to be superior to clomid in achieving live birth rates in women with infertility and polycystic ovary syndrome. However, the combination of these medications has not been studied. This is a pilot study to evaluate if the combination treatment has improved efficacy as measured by ovulation rate.
This is a randomized controlled trial of letrozole versus letrozole and clomiphene citrate (CC) for one menstrual cycle. Women will be randomized in a 1:1 ratio to receive letrozole 2.5 mg or combination of letrozole 2.5 mg and clomiphene 50 mg for 5 days on days 3-7 of menstrual cycle. The women and their partners will be instructed to have regular intercourse with the intent to conceive during the cycle. Patients will have an transvaginal ultrasound mid cycle and to evaluate number of follicles (>15 mm), follicle size, endometrial thickness and pattern. Patients will have mid- luteal phase progesterone level drawn to evaluate ovulation. Side effect profile will also be monitored.
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
- 否
入选标准
- •Willing to comply with all study procedures and be available for the duration of the study
- •Diagnosis of infertility: Inability of couple to achieve successful pregnancy after 12 months of regular timed unprotected intercourse in women less than 35 years of age; and after 6 months of regular intercourse without use of contraception in women 35 years and older
- •Diagnosis of polycystic ovary syndrome based on Revised Rotterdam criteria
- •Ability to have regular intercourse during the ovulation induction phase of the study
- •Normal sperm concentration of 15 million/mL and with normal motility of > 40% according to World Health Organization cutoff points, in at least one ejaculate during the previous year
排除标准
- •Current pregnancy
- •Current use of hormonal contraception; use of any type of combined contraceptive or oral progestins within the past month; or use of hormonal implants or depo progestins within the past 3 months
- •Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities
- •Uncorrected thyroid disease
- •Untreated hyperprolactinemia.
- •Medical conditions in which avoiding pregnancy is recommended until under improved control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension
- •Contraindications to clomiphene citrate: hypersensitivity to CC or any of its components, history of liver disease or known liver disease, unknown cause of abnormal uterine bleeding, or intracranial lesion
- •Contraindications to letrozole: hypersensitivity to letrozole or any of its components.
- •Use of medications known to affect reproductive function or metabolism or that are an absolute contraindication during pregnancy within the past month.
- •If patients are suspected based on clinical findings for other etiologies that mimic PCOS, work up must be completed to exclude other etiologies prior to enrollment (i.e. Cushing's syndrome, androgen-secreting tumor).
研究组 & 干预措施
Letrozole
Letrozole 2.5 mg orally for 5 days on cycle days 3-7
干预措施: Letrozole (Drug)
Letrozole + Clomiphene
Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7
干预措施: Clomiphene (Drug)
Letrozole + Clomiphene
Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7
干预措施: Letrozole (Drug)
结局指标
主要结局
Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level
时间窗: 7 days following LH surge or at cycle day 21 if no LH surge was detected
Ovulation: mid-luteal progesterone \> /=3 ng/mL. No ovulation: mid-luteal progesterone \<3ng/mL.
次要结局
- Number of Developing Follicles(Cycle day 12-14)
- Size of Largest Developing Follicle(Cycle day 12-14)
- Endometrial Thickness(Cycle day 12-14)
- Conception(5 weeks after treatment)
- Clinical Pregnancy(6-7 weeks after treatment)
- Multiple Gestation(9-10 months after treatment)
- Live Birth(9-10 months after treatment)
- Pregnancy Loss(9-10 months after treatment)
研究者
Rachel Mejia
Associate Fellow
University of Iowa