2024-512844-40-00招募中4 期
Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial
Vaestra Goetalandsregionen11 个研究点 分布在 2 个国家目标入组 1,800 人开始时间: 2024年6月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
- 试验地点
- 11
- 主要终点
- Live birth
研究概览
简要总结
The primary objective is to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth per woman undergoing FET-NC, and if superiority is shown, if 7 weeks of progesterone treatment is superior to 3 weeks treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Planned for a FET-NC with a blastocyst
- •Age≥18<43 years
- •BMI≥18.5<35
- •Regular menstrual cycles 24-35 days
- •Given informed consent
- •Understand written and spoken Swedish, English or Arabic
排除标准
- •ART-related: Oocyte donor cycles. Preimplantation Genetic Testing (PGT) cycles. Uterine malformation, precluding cervical access to the uterine cavity. Submucous myoma and endometrial polyps requiring surgery before transfer of embryo.
- •Drug-related: Hypersensitivity against study medication. Other contraindications according to FASS: Undiagnosed vaginal bleeding, severely impaired liver function or liver disease, known or suspected malignancy of breast or genital region, ongoing arterial or venous thromboembolism, porphyria or history of these conditions (FASS.se).
- •Development of serious disease contraindicating ART or pregnancy.
- •Participation or recent participation in a clinical study with an investigational product (during the past 30 days). Previous participation in this study.
结局指标
主要结局
Live birth
Live birth
次要结局
- Biochemical pregnancy, clinical pregnancy, ongoing pregnancy, term pregnancy, miscarriage, ectopic pregnancy, termination of pregnancy, intrauterine fetal death, perinatal death.
- Perinatal outcomes: birth weight, gestational age, preterm birth (PTB), very PTB, low birth weight (LBW), very LBW, stillbirth, perinatal death (stillbirth + early neonatal death = neonatal death <7 days), birth defects detected at birth.
- Obstetric outcomes: hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) (HDP), placenta previa, placenta abruption, postpartum hemorrhage (PPH).
- Cost-effectiveness
- Progesterone levels in blood samples from day LH+3
研究者
Christina Bergh
Scientific
Vaestra Goetalandsregionen
研究点 (11)
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