Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- OVULATION RATE
研究概览
简要总结
The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as PCOS according to Roterdam (2003) criteria
- •patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
- •patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
- •normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
- •normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
- •no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.
排除标准
- •1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- >40 years old. 4- body mass index (BMI) >26 kg/m
- •5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.
研究组 & 干预措施
Group A Letrozole group
2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days.
干预措施: group A 2.5 mg letrozole oral tablets (Drug)
Group B laparoscopic ovarian drilling group
bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.
干预措施: laparoscopic ovarian drilling (Procedure)
结局指标
主要结局
OVULATION RATE
时间窗: 7 DAYS BEFORE NEXT MENSES
SERUM PROGESTERON LEVEL
次要结局
- BIOCHEMICAL PREGNANCY RATE(AFTER 30 DAYS OF INTERVENTION)
- CLINICAL PREGNANCY RATE(AT 6 WEEKS GESTATION)
研究者
Ahmed Abdel Shafy El Shahawy
Lecturer
Ain Shams University