A Randomized Trial of Letrozole as an Adjunct to Follicle Stimulating Hormone in Stimulated in Vitro Fertilization Cycles
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
In-vitro fertilization (IVF) is the treatment of choice for couples with prolonged infertility. The treatment usually involves hormonal stimulation of the ovaries by follicle stimulating hormone (FSH), followed by surgical removal of eggs which are then mixed with sperm in the laboratory to create embryos. The success rates of IVF treatment remain unsatisfactory and are no longer increasing. One of the reasons is an adverse effect of high serum estradiol levels following FSH stimulation on the lining of the uterus.
Letrozole is a drug used in the prevention of recurrence of breast cancer because of its action to reduce the intra-ovarian aromatization of androgens to estrogens. It is now increasingly used for ovulation induction and is as safe as clomiphene citrate. Use of letrozole during standard ovarian stimulation for IVF producing adequate numbers of oocytes with physiological levels of estradiol may increase the present success rate of standard IVF treatment.
The aim of this randomized study is to compare the live birth rate of FSH alone versus combined FSH and letrozole used for ovarian stimulation in IVF treatment.
详细描述
Trial design:
Infertile women undergoing IVF treatment will be randomized into one of the following two groups by an online randomization program:
Letrozole group: letrozole 2.5mg daily will be given at the start of the antagonist during ovarian stimulation i.e. day 5 of stimulation.
Control group: standard care with FSH alone during ovarian stimulation.
Intervention:
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women under 42 years of age
- •medical indication for IVF treatment
- •antral follicle count prior to ovarian stimulation >=3
- •informed consent
排除标准
- •women using donor oocytes
- •women undergoing preimplantation genetic diagnosis
- •women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
- •women with hydrosalpinges shown on scanning and not corrected
- •previous documented poor response (<=3 oocytes) to ovarian stimulation using at least FSH 225 IU daily
研究组 & 干预措施
Letrozole group
Letrozole + standard treatment:
Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration.
干预措施: Letrozole (Drug)
结局指标
主要结局
Live birth rate
时间窗: through study completion, an average of 1 year
A baby born alive after 20 weeks gestation
次要结局
- Miscarriage rate(up to 20 weeks of gestation)
- Number of follicles > 12 mm on day of hCG (or the day before)(about 2 weeks)
- Complications of pregnancy(through study completion, an average of 1 year)
- Number of oocytes obtained(On the operation day of transvaginal ultrasound guided oocyte retrieval)
- Ovarian hyperstimulation rate(about 1 month)
- Oocyte fertilization rate(2-3 days after the transvaginal ultrasound guided oocyte retrieval operation)
- Clinical and ongoing pregnancy rates(up to 20 weeks)
- Total IU of FSH used per cycle(about 2 weeks)
- Number and quality of embryos obtained(2-3 days after the transvaginal ultrasound guided oocyte retrieval operation)
- Follicular fluid testosterone level(On the operation day of transvaginal ultrasound guided oocyte retrieval)
- Follicular fluid AMH level(On the operation day of transvaginal ultrasound guided oocyte retrieval)
- Endometrial thickness on day of hCG (or the day before)(on day of hCG (or the day before))
- Serum E2 level on day of hCG administration (or the day before)(on day of hCG administration (or the day before))
- Serum P levels on day of hCG administration (or the day before)(on day of hCG administration (or the day before))
- Serum testosterone levels on day of hCG administration (or the day before)(on day of hCG administration (or the day before))
- Proportion of oocytes resulting in top quality day 2 (or day 3) embryos according to validated morphological criteria.(2-3 days after the transvaginal ultrasound guided oocyte retrieval operation)
- Follicular fluid E2 level(On the operation day of transvaginal ultrasound guided oocyte retrieval)
- Follicular fluid inhibin B level(On the operation day of transvaginal ultrasound guided oocyte retrieval)
- Reported side effects(through study completion, an average of 1 year)