Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- early pregnancy loss
研究概览
简要总结
To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age more than or equal to 18 and less than or equal to 40
- •BMI more than or equal to 18 and less than or equal to 35
- •Diagnosis of PCOS according to Rotterdam criteria
- •Normal gynaecological ultrasound < 6 months before inclusion
- •Signed informed consent form
- •Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage
排除标准
- •Recurrent implantation failure
- •Recurrent miscarriage
- •Presence of adenomyosis
- •Untreated intrauterine pathology
- •rAFS (revised American Fertility Society) Grade III or IV endometriosis
- •Hydrosalpinx
- •In vitro maturation (IVM)
- •Untreated autoimmune disorders
- •(History of) malignancy
- •Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past
- •Pre-implantation genetic testing (PGT)
研究组 & 干预措施
Hormonal Replacement Therapy
Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.
干预措施: estradiol valerate (Drug)
Letrozole
Using letrozole for ovulation induction before planning the frozen embryo transfer
干预措施: Letrozole (Drug)
结局指标
主要结局
early pregnancy loss
时间窗: 12 weeks after frozen embryo transfer
次要结局
- cancellation rate(2 months)
- endometrial thickness on the day of planning of FET(1 day)
- neonatal birth weight(1 year)
- term of delivery(1 year)
- number of visits to the clinic(2 months)
- implantation rate(1 day)
- biochemical and clinical pregnancy rate(12 weeks)
- live birth rate(1 year)
- hypertensive disorders of pregnancy(1 year)
研究者
Liese Boudry
Medical doctor
CRG UZ Brussel