Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- endometrial receptivity gene expression profile
研究概览
简要总结
Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS) still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.
By testing different luteal support protocols on women undergoing GnRHa triggering, the investigators aim to find out which protocol resembles the most the gene expression profile observed after hCG triggering and conventional luteal phase support, in order to choose it as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subjects with current or previous history of an endocrine abnormality
- •Subjects with an abnormal outcome of blood biochemistry or hematology
- •Subjects with an abnormal cervical smear
- •Subjects with a chronic disease
- •Subjects with any relevant ovarian-, tubal- or uterine-pathology that could interfere with the COS treatment
- •Pregnancy
- •Subjects who had a previous history of ovarian hyperresponse or ovarian hyperstimulation syndrome (OHSS), polycystic ovary syndrome (PCOS) or a basal antral follicle count (AFC) of more than 20 on ultrasound (11 mm, both ovaries combined) .
- •Previous low ovarian response to FSH or hMG treatment (i.e. cycle cancelled due to insufficient ovarian response or less than 6 oocytes obtained).
- •A history of recurrent miscarriage,
- •Smoking more than 10 cigarettes per day.
- •Not willing to comply with study procedures
研究组 & 干预措施
hCG
干预措施: hCG (Drug)
Triptorelin 0.2mg s.c.
干预措施: triptorelin (Drug)
0.2mg triptorelin plus estradiol/progesterone
干预措施: Triptorelin, estradiol valerate, micronized vaginal progesterone (Drug)
0.2mg tripoterlin plus single bolus hCG 1500 IU
干预措施: triptorelin, hCG (Drug)
0.2mg tripoterlin plus multiple boluses hCG 500 IU
干预措施: triptorelin, hCG (Drug)
0.2mg tripoterlin plus multiple doses recLH
干预措施: triptorelin, recombinant LH (Drug)
结局指标
主要结局
endometrial receptivity gene expression profile
时间窗: participants will be followed for the duration of the cycle, an expected average of 4 weeks
次要结局
- Incidence of moderate/severe OHSS in all different treatment group(participants will be followed for the duration of the cycle, an expected average of 4 weeks)