Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 110
- 主要终点
- ovulation rate
研究概览
简要总结
110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly :
- 55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.
- 55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.
Patients will be subjected to:
Complete history taking:
- Details about name, age
- Menstrual history with determination of menarche
- Amenorrhea or oligomenorrhea , Regularity of the cycle
- History of endocrine disease.
- History of previous operations.
- Physical examination:
- General examination:
With special concern to:
--Acne.
--Hirsutism .
--Weight.
--Height
--BMI was determined :
Wt. in kg ـــــــــــــــــــ =
) Height in m)2
- Abdominal examination :
-
for scar of previous pelvic or abdominal operations .
-
Pelvic examination :
-
vaginal examination for enlarged cystic ovaries.
-
ultrasound for diagnosis of pcos.
PARAMETERS:
(1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy
详细描述
The aim of this study is to compare the efficacy of letrozole on ovulation induction to that of clomiphene citrate in women suffering polycystic ovary syndrome.
Research question:
In women with PCOS , dose letrozole effective in ovulation induction as clomiphene citrate?
Researcher hypothesis:
In women with pcos , letrozole may be as effective as clomiphene citrate in ovulation induction.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 20-35
- •Primary or secondary infertility
- •Patients diagnosed as PCOs according to Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003)
排除标准
- •Any patients have any causes of infertility other than which mentioned in the inclusion criteria as:
- •Hyperprolactinemia.
- •Male factor of infertility.
- •WHO Guidelines 2010 for Normal seminal fluid analysis :
- •Volume> 1.5 ml
- •ph 7.2 to 8.0
- •Liquefaction time 20 to 30 min
- •Sperms concentration >15 million/ml
- •Total motility 40%(Progressive motility + non progressive motility)
- •Progressive motility 32%
- •Morphology > 4% normal forms
- •Thyroid dysfunction.
- •Diabetes Mellitus.
- •Known or suspicious tubal factor infertility by HSG or laparoscope.
- •Endometrioses or pelvic inflammatory diseases .
研究组 & 干预措施
letrozole
patients receive letrozole 2.5 mg twice daily from day 2 to day 6 of the cycle , for 3 consecutive cycles, hcg hormone10.000 iu im injection is given when mature follicle diameter reach 18 mm by trans vaginal ultrasound.
干预措施: Letrozole (Drug)
letrozole
patients receive letrozole 2.5 mg twice daily from day 2 to day 6 of the cycle , for 3 consecutive cycles, hcg hormone10.000 iu im injection is given when mature follicle diameter reach 18 mm by trans vaginal ultrasound.
干预措施: hcg hormone (Drug)
clomiphene citrate
patients will receive clomiphene citrate 50 mg twice daily from day 2 to day 6 of the cycle for 3 consecutive cycles , hcg 10.000 hormone iu im injection is given when mature follicle diameter reach 18 mm by trans vaginal ultrasound .
干预措施: Clomiphene citrate (Drug)
clomiphene citrate
patients will receive clomiphene citrate 50 mg twice daily from day 2 to day 6 of the cycle for 3 consecutive cycles , hcg 10.000 hormone iu im injection is given when mature follicle diameter reach 18 mm by trans vaginal ultrasound .
干预措施: hcg hormone (Drug)
结局指标
主要结局
ovulation rate
时间窗: up to 24 weeks.
Follicular monitoring will be done by transvaginal ultrasonography (TVS) on alternate days from day 9 of menstrual cycle until a mature follicle detected. Follicle considered mature when it attained 18 mm in size or more by averaging inner two diameters of the follicle. * A single injection of 10,000 IU hCGwill be given, if at least one follicle attained 18 mm. TVS will be done after 48 h of hCG injection to determine follicle rupture. If the follicle found unruptured, TVS repeated after 72 h of the hCG injection to detect whether follicle has ruptured or not. Ovulation ascertained by observing rupture of the follicle by ultrasonogram (USG). * Endometrial thickness of 8 mm considered a satisfactory response of the endometrium. * on day 21 serum progesterone level will measured. A progesterone level of 10 ng/ml considered as ovulatory. * Ovulation rate is assessed by number of mature follicle (diameter 18-22 mm) per cycle .
次要结局
- day 21 progesterone level(up to 24 weeks)
- Endomertial thickness(up to 24 weeks)
- On gowing pregnancy(up to 24 weeks)
- Chemical pregnancy(up to 24 weeks)
研究者
mostafa gomaa hamid halawa
Clinical Professor
Ain Shams Maternity Hospital