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临床试验/NCT05089383
NCT05089383Unknown不适用

Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

University of Athens1 个研究点 分布在 1 个国家目标入组 698 人开始时间: 2021年9月14日最近更新:
适应症
干预措施
相关药物

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

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

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikos Vlahos

Professor of Obstetrics, Gynecology and Assisted Reproduction

University of Athens

研究点 (1)

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