Impact of Different Strategies in Frozen Cycles Using HRT in Normo Responding Patients Undergoing IVF/ICSI Cycles: a Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- live birth
研究概览
简要总结
In the absence of robust contemporary data, investigators decided to perform a multicenter cohort study of various IVF centers, to compare the different modalities used for pregnancy rates following frozen-thawed embryo transfer (FET) treatment cycles in normoovulatory patients undergoing IVF/ICSI.
详细描述
In general, the type of FET protocol for each patient is selected by the attending physicians at their own discretion. In all centers, patients with ovulatory cycles are typically prescribed an NC-FET or mNC-FET, whereas patients with oligomenorrhoea or amenorrhoea are prescribed an artificial cycle to prepare the endometrium for FET.
Ovarian stimulation protocol
- The antagonist protocol
- The long 21 /2 agonist protocol Laboratory technique
a. IVF or b. ICSI Embryo freezing using only vitrification will be performed in days 3 or 5/6. Embryo transfer will be conducted at days 3 or 5/6. The maximum number of embryos transferred will be two, as in accordance to the Hellenic legislation.
The following modalities will be analyzed, patients with:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 25 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 25-39 years, BMI ≤ 35 and ≥ 19, normo-ovulatory patients and basal FSH ≤11 mIU/mL. Definition of expected normal ovarian response will be based primarily on antral follicle count (AFC) between 6-14.
排除标准
- •history of more than three previous unsuccessful IVF/ICSI cycles, FSH > 12 mIU/mL, BMI >35 or <19, poor ovarian response according to the 2011 Bologna criteria, PCOS patients according to the Rotterdam criteria, history of untreated autoimmune, endocrine or metabolic disorders, history of pathology affecting the endometrial cavity and/or receptivity and clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit and patients without embryo after thawing.
研究组 & 干预措施
Group 1
Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support
干预措施: Hormone Replacement cycle 1 (Drug)
Group 2
Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone)
干预措施: Hormone Replacement cycle 1 (Drug)
Group 3
Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone)
干预措施: Hormone Replacement cycle 2 (Drug)
Group 4
Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)
干预措施: Hormone Replacement cycle 2 (Drug)
结局指标
主要结局
live birth
时间窗: 1 year
birth after 20 weeks of gestation
ongoing pregnancy
时间窗: 3 months
positive heart rate after 12 weeks
miscarriage
时间窗: 6 months
pregnancy loss up to 20 weeks of gestation
次要结局
- biochemical pregnancy (positive β-hCG), multiple, ectopic and clinical pregnancy rates(3 months)
研究者
Siristatidis Charalampos, MD, PhD
Associate Professor in Obstetrics Gynaecology
National and Kapodistrian University of Athens