Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of ovulation.
研究概览
简要总结
Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.
详细描述
Participants fulfilling inclusion and exclusion criteria will be divided into two groups, each group containing 300 participants;
Group (A):
300 participants will receive Clomiphene citrate oral tablets and placebo of Tamoxifen oral tablets.
Group (B):
300 participants will receive Tamoxifen oral tablets and placebo of Clomiphene oral tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary infertility.
- •Body mass index (BMI) between 25 and 30 Kg/m
- •Polycystic ovary syndrome (using ESHRE/ASRM criteria).
排除标准
- •Secondary infertility.
- •Patients with BMI under 25 or over 30 Kg/m
- •Hyper or hypothyroidism, or hyperprolactinemia.
- •Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
- •Intention to start a diet or a specific program of physical activity.
- •Organic pelvic diseases.
- •Tubal or male factor infertility.
- •Interval of earlier treatment with any of the fertility drugs of less than 6 months.
- •Contraindication to either:
- •Clomiphene citrate.
- •Tamoxifen.
- •HCG injection.
研究组 & 干预措施
Clomiphene citrate + placebo
Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.
干预措施: Clomiphene citrate (Drug)
Clomiphene citrate + placebo
Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.
干预措施: Tamoxifen Placebo (Drug)
Tamoxifen + placebo
Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.
干预措施: Tamoxifen (Drug)
Tamoxifen + placebo
Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.
干预措施: Clomiphene citrate placebo (Drug)
结局指标
主要结局
Rate of ovulation.
时间窗: Up to 4 weeks from starting treatment.
* Transvaginal ultrasound done to: 1. Detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size. * Serum progesterone will be measured in the mid luteal day of the cycle, where: 1. Level 6 ng/ml or 19 nmol/L indicates Ovulation. 2. Level \<5 nmol/L suggests Ovulation did not occur.
次要结局
- Number of growing follicles detected by transvaginal ultrasound.(Up to 4 weeks from starting treatment.)
- Adverse effects: such as headache, nausea, vomiting, breast tenderness, blurred vision, and ovarian enlargement or hyperstimulation.(Up to 4 weeks from starting treatment.)
- Endometrial perfusion by using 3D- power Doppler (GE Medical system volouson E6, 5-7 MHz) in the mid luteal day of the cycle to assess endometrial receptivity.(Up to 4 weeks from starting treatment.)
- Endometrial thickness and quality in the pre-ovulatory period.(Up to 4 weeks from starting treatment.)
- Pregnancy rate both clinical and biochemical.(Up to 8 weeks from starting treatment.)
- Patient compliance.(Up to 4 weeks from starting treatment.)
研究者
Mohamed S Sweed, MD
Lecturer
Ain Shams University