Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial
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
- 1
- 主要终点
- Number of participants with live birth
研究概览
简要总结
The ProFET study aims to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer (FET), in a natural cycle (NC) after in-vitro fertilization (IVF), and if 7 weeks of treatment is superior to 3 weeks duration.
详细描述
Vaginal progesterone supplementation is routine treatment after IVF with fresh embryo transfer, but it is uncertain whether vaginal progesterone after frozen embryo transfer in natural cycles is efficacious in terms of increasing the chance of a live birth.
The ProFET study is a multicenter, open randomized, controlled trial planning to include 1800 women, intended to undergo a FET in a natural cycle.
Primary objectives are to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer, in a natural cycle and if 7 weeks of treatment is superior to 3 weeks duration.
Secondary objectives are to compare groups regarding pregnancy outcomes including biochemical pregnancy, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy, and ectopic pregnancy.
Secondary objectives are also perinatal and obstetrics outcomes, self-reported side effects, adverse events and cost effectiveness.
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
- •Planned for a FET-NC with a blastocyst
- •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
- •Oocyte donor cycles, preimplantation genetic testing (PGT) cycles. Uterine malformation, submucous myoma and endometrial polyps.
- •Hypersensitivity against study medication. Other contraindications according to www.fass.se
- •Development of serious disease contraindicating ART or pregnancy.
- •Participation or recent participation in a clinical study with an investigational product (past 30 days). Previous participation in this study.
研究组 & 干预措施
Progesterone for 3 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.
干预措施: Progesterone vaginal tablet (Drug)
Progesterone for 7 weeks
At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.
干预措施: Progesterone vaginal tablet (Drug)
结局指标
主要结局
Number of participants with live birth
时间窗: Up to 41 weeks after embryo transfer.
A child born alive. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.
次要结局
- Very low birth weight(Up to 41 weeks after embryo transfer.)
- Number of children with birth defects(Up to 41 weeks after embryo transfer.)
- Number of participants with biochemical pregnancy(2-3 weeks after embryo transfer.)
- Number of participants with ongoing pregnancy(5-7 weeks after embryo transfer.)
- Number of participants with termination of pregnancy(Up to 20 weeks after embryo transfer.)
- Birth weight(Up to 41 weeks after embryo transfer.)
- Very preterm birth(Up to 30 weeks after embryo transfer.)
- Perinatal death(Up to 41 weeks after embryo transfer and 7 days after birth.)
- Number of participants with hypertensive disorders of pregnancy(Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.)
- Preterm birth(Up to 35 weeks after embryo transfer.)
- Low birth weight(Up to 41 weeks after embryo transfer.)
- Stillbirth(Up to 41 weeks after embryo transfer.)
- Cost effectiveness(After study completion, an average of 1 year.)
- Number of participants with clinical pregnancy(4-8 weeks after embryo transfer.)
- Number of participants with miscarriage(Up to 20 weeks after embryo transfer.)
- Number of participants with ectopic pregnancy(Up to 20 weeks after embryo transfer.)
- Number of children admitted to Neonatal Intensive Care Unit (NICU)(Up to 41 weeks after embryo transfer and 7 days after birth.)
- Number of participants with postpartum hemorrhage(Up to 41 weeks after embryo transfer.)
- Number of participants with Cesarean section(Up to 41 weeks after embryo transfer.)
- Number of participants with treatment related side effects(Up to 8 weeks after embryo transfer.)
- Number of participants with adverse events(Up to 8 weeks after embryo transfer.)
- Gestational age at delivery(Up to 41 weeks after embryo transfer.)
- Number of participants with placenta previa(Up to 41 weeks after embryo transfer.)
- Number of participants with thromboembolic events(Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.)
- Maternal mortality(Up to 41 weeks after embryo transfer including the postpartum period before discharge of mother.)
- Number of participants with placenta abruption(Up to 41 weeks after embryo transfer.)