NCT04806919已完成3 期
Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent form (ICF) dated and signed
- •Age ≥ 18 and < 43 years old
- •Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2
- •Less than 4 previous Assisted Reproductive Technologies (ART) cycles
- •Current pregnancy wish
- •Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)
排除标准
- •Simultaneous participation in another clinical study
- •Previous participation in this study
- •Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
- •Repeated miscarriages (> 2 miscarriages)
- •Untreated and uncontrolled thyroid dysfunction
- •Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- •Abnormal vaginal bleeding without a known/diagnosed cause
- •Ovarian cysts or enlarged ovaries
- •Fibroid tumors of the uterus incompatible with pregnancy
- •Malformations of the reproductive organs incompatible with pregnancy
- •Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
- •Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia
- •Active smoking
- •Ongoing pregnancy
- •Use of carbamazepine, rifampicin or phenytoin
- •Those unable to comprehend the investigational nature of the proposed study
研究组 & 干预措施
Intervention group: Amelgen ® 400 mg TID
Experimental
Increase daily progesteron dose
干预措施: Progesteron TID (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 7 gestational weeks (+ or - 1 week)
visualization of an embryo with a heart beat
次要结局
- Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate(7 gestational weeks (+ or - 1 week))
研究者
研究点 (2)
Loading locations...
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