Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 698
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.
详细描述
In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.
According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.
But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).
The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.
The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
- •Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.
排除标准
- •Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels> 15 IU / ml, major surgery in the ovaries (removal), and age <22 years and > 40 years old.
- •Active pelvic inflammatory disease
- •IVF/ICSI with donor eggs
- •Previous participation in this trial
研究组 & 干预措施
combined progesterone group
patients will receive vaginal plus subcutaneous or per os progesterone
干预措施: Utrogestan (Drug)
Vaginal progesterone group
patients will receive vaginal progesterone
干预措施: Utrogestan (Drug)
结局指标
主要结局
Live birth rate
时间窗: 9 months]
The percentage of viable embryo after 20 weeks of gestation
Abortion rate
时间窗: 20 weeks
Loss of pregnancy up to 20 weeks of gestation
次要结局
未报告次要终点
研究者
Nikos Vlahos
Professor of Obstetrics, Gynecology and Assisted Reproduction
University of Athens
