Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
详细描述
In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy.
In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed.
Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy.
Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.
But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with a documented history of infertility who underwent IVF with or without ICSI, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent.
- •Body mass index ≥18 to ≤35 kg/m2
- •LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening
- •Normal transvaginal ultrasound at screening (or within 14 days prior to screening)
- •Planning a transfer of 1 or 2 fresh embryos.
排除标准
- •Previous participation in this trial
- •Subjects with >2 unsuccessful IVF attempts
- •Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;
- •Recent major surgery (within 3 months);
- •Current or recent substance abuse, including that of alcohol and tobacco;
- •History of chemotherapy;
- •History of recurrent pregnancy loss (≥3 previous miscarriages)
研究组 & 干预措施
StudyGroup
Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support
干预措施: Dydrogesterone 10mg Oral Tablet (Drug)
结局指标
主要结局
Live birth rate
时间窗: 9 month
The percentage of live newborns in the total cycles of treatment
次要结局
- Rates of Newborn malformations(1 year)
- Presence of fetal heartbeats at 12 weeks of gestation(12 weeks)
- Rates of obstetrical complications(9 months)
- Newborn outcomes(1 year)
- Frequency of positive pregnancy tests on Day 14 after embryo transfer(14 days)
- Newborn Weight(9 months)
研究者
Amir Weintraub
Director, IVF Unit
Laniado Hospital