Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Serum estradiol
研究概览
简要总结
The aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles.
详细描述
Enrolled women will be randomized based on their ovulation pattern. Ovulatory women will be randomized to either natural cycle or estradiol + progesterone substituted cycle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone substituted cycle or gonadotropin stimulated cycle treatment for FET.
Included women will undergo blood testing every two weeks for serum estradiol and progesterone levels until gestational age 9+6. Routine vaginal ultrasounds will be performed as well as additional pregnancy ultrasounds.
Secondary obstetric outcomes will be investigated using the womens medical journals.
All the treatments are considered standard treatments for FET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years < 40 years
- •BMI < 35 kg/m2
- •Normal wet smear within the past three years
- •Thawed blastocysts (day 5 or 6) after either IVF or ICSI treatment
排除标准
- •Age < 18 years
- •BMI > 35 kg/m2
- •Oocyte donation
- •HIV/ hepatitis
- •Undiagnosed vaginal bleeding
- •Uterine malformations
- •Persisting ovarian cysts
- •Tumors in Hypothalamus, pituitary, thyroid or adrenal
- •Previous breast cancer
- •Unregulated thyroid disease
- •Cardiovascular disease
- •Breast feeding
- •Present or previous chemotherapy/radiation therapy
- •Present or previous malignant disease
- •Alcohol/drug abuse
研究组 & 干预措施
Natural cycle
These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer
干预措施: Chorionic Gonadotropin, Alpha (Drug)
Estradiol and progesterone
These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6
干预措施: Estradiol Tablets (Drug)
Estradiol and progesterone
These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6
干预措施: Progesterone (Drug)
Gonadotropin
These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.
干预措施: Follitropin Alfa (Drug)
Gonadotropin
These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.
干预措施: Chorionic Gonadotropin, Alpha (Drug)
结局指标
主要结局
Serum estradiol
时间窗: 10 weeks
Blood samples in the first 10 weeks of pregnancy
Serum progesterone
时间窗: 10 weeks
Blood samples in the first 10 weeks of pregnancy
次要结局
- Child malformations(9 months)
- Obstetric complications(9 months)
- Child birth weight(At delivery)
- Gestational age at delivery(At delivery)
研究者
Pernille Fog Svendsen, DMSc
DMSc
Copenhagen University Hospital at Herlev