Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Serum progesterone level
研究概览
简要总结
This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.
This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens.
- •Age between 18 and 50 years.
- •Normal uterine cavity verified by imaging techniques.
- •Serum progesterone documented on the day of embryo transfer.
排除标准
- •Patients with a history of endometritis.
- •Patients diagnosed with Asherman's syndrome.
- •Patients with a different supplementation regimen or doses than those of the study groups.
研究组 & 干预措施
400 mg
Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day.
干预措施: Vaginally administered progesterone (Drug)
200 mg
Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day.
干预措施: Vaginally administered progesterone (Drug)
结局指标
主要结局
Serum progesterone level
时间窗: On the day of embryo transfer
次要结局
- Need for additional progesterone supplementation(assessed on the day of the embryo transfer)
- Clinical results (ongoing pregnancy and miscarriage rate)(assessed on the day of the pregnancy test and during the pregnancy evolution)
研究者
Joaquín Llácer
Principal Investigator
Instituto Bernabeu