Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical pregnancy
研究概览
简要总结
The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction
详细描述
Frozen-thawed transfer embryo are more and more frequent but to date, there is no consensus on the ideal management of the adequate endometrial preparation.
Artificial preparation of endometrium is commonly used in assisted reproduction center because it is more easy to schedule.
Estradiol could be administrate by oral, vaginal or transdermal, but no protocol seems to improve clinical pregnancy rates.
To investigator's knowledge, transdermal estradiol has never been compare to vaginal administration before frozen-thawed embryo transfer.
Because transdermal administration could improve satisfaction of patients and reduce duration of treatment (when compare to oral administration), the investigators conduct a prospective study to compare clinical pregnancy rate after transdermal or vaginal estradiol administration to prepare the endometrium before frozen-thawed embryo transfer.
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
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 and <43
- •frozen-thawed embryo transfer after exogenously administered estrogen in either way transdermal or vaginal
- •patients who accepted being included and signed the consent forms.
排除标准
- •patient who refuse to participate
- •frozen-thawed embryotransfer after stimulated or natural cycle
- •oocyte or sperm donation
- •endometrial thickness after 21 days <6mm
- •non-french speaking patients
- •women under legal guardianship
- •women with no health or social security coverage
研究组 & 干预措施
transdermal
transdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks.
干预措施: Estradiol 100 µg (Drug)
vaginal
Vaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks
干预措施: Estradiol 2 MG (Drug)
结局指标
主要结局
clinical pregnancy
时间窗: 12 weeks
defined as fetal cardiac activity at 12 weeks of gestation
次要结局
- treatment duration(21 days)
- chemical pregnancy(6 weeks)
- plasmatic lh concentration on the day of transfer(21 days)
- plasmatic progesterone concentration on the day of transfer(21 days)
- annulation(21 days)
- satisfaction evaluated by anonymous survey the day of transfer(1 month)
- spontaneous pregnancy loss(12 weeks)
- plasmatic estradiol concentration on the day of transfer(21 days)
- endometrial thickness(21 days)