Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 主要终点
- Evidence of ovulation
研究概览
简要总结
There is an increased prevalence of high Body mass index (BMI) all over the world.High BMI is shown to have an impact on the female reproductive system.It can contribute to both ovulatory and anovulatory subfertility.
Clomiphene citrate and Letrozole have been used for treatment of infertility.Both are used for induction of ovulation.
Clomiphene citrate is an estrogen receptor antagonist .It increases serum FSH and it has its limitation due to his antiestrogenic effect,it has an ovulation rate 70-80% but pregnancy rate is only 22% because of its anti-estrogenic effect on endometrium and poor cervical mucus (Legro RS et al.,2007) Letrozole is an aromatase inhibitor which inhibits the production of estrogen, which influences the action of the brain's hypothalamus and pituitary on the functioning of the ovaries by increasing FSH.Due to the antiestrogenic effect of clomiphene citrate,Letrozole can be used as an alternative.
The investigators are comparing the effect of both medications on the outcome of the induction of ovulation in women with high BMI.
详细描述
This is a Randomized controlled trial .The researchers include160 women with BMI more than 30 who were suffering from subfertility for more than 2 years. The investigators will randomise them into 2 groups. Group A:They were prescribed 100 mg of clomiphene citrate from day 2-5 of the cycle for 5 days. Group B : They were prescribed 5 mg of Letrozole from day 2-5 of the cycle.
Vaginal ultrasound was performed on day 11 of the cycle, After at least one follicle reached 15 mm, The patient was encouraged to have sexual intercourse every other day for few days.The patients will have a midluteal progesterone level to confirm ovulation and will have a pregnancy test in 2 weeks if missed period. The researchers will compare the number of mature follicles, endometrial thickness on the day when there are mature follicles, occurrence of pregnancy, multiple pregnancies, and miscarriages .
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-45 years old.
- •History of subfertility for 2 years.
- •No previous IVF
- •Intact tubes as evidenced by HSG or Hycosy
- •Normal Sperm parameters according to WHO criteria.
- •Ability to have regular intercourse during the ovulation induction phase of the study.
排除标准
- •Age less than 18 years old or older than 45 years old.
- •FSH> 15 mIU/ml
- •Tubal factor of infertility
- •Male factor of infertility
- •Current pregnancy,abnormal uterine bleeding.
- •History of use of hormonal contraception in the last 3 months.
- •Untreated medical problems: thyroid disease,hyperprolactinemia or contraindication to pregnancy as uncontrolled diabetes or severe heart disease.
- •Contraindications to clomiphene citrate: hypersensitivity to clomid.
- •Contraindications to letrozole: hypersensitivity to letrozole .
研究组 & 干预措施
Clomiphene Citrate-High BMI women
Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
干预措施: Clomiphene Citrate 50mg (Drug)
Letrozole-High BMI women
Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
Evidence of ovulation
时间窗: day 21 of 28 day cycle or 7 days post LH surge
Raised concentration of serum progesterone
次要结局
- Endometrial thickness(day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days))
- Number of mature follicles(day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days))
- Conception(4-5 weeks post treatment)
- clinical pregnancy(6 weeks post treatment)
研究者
Eman Elkattan
Associate professor
Cairo University