Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Miscarriage rate before 8 weeks of gestation
研究概览
简要总结
The aim of the current study is to compare miscarriage rates (before 8 weeks) between a true natural cycle (awaiting spontaneous LH surge) and a hormone replacement therapy cycle prior to blastocyst transfer in preimplantation genetic testing (PGT) patients, with biopsy on day 5 of embryonic development. The advantage of performing the study in PGT patients is the exclusion of aneuploidy as a cause of miscarriage.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI under 35 kg/m2
- •Regular menstrual cycle pattern (i.e. 24-35 days cycle)
- •First, second and third ICSI-PGT cycle
- •First frozen embryo transfer cycle following a fresh ICSI-PGT attempt
- •PGT with trophectoderm biopsy on day 5 of embryonic development
- •Signed informed consent
排除标准
- •Oligo-amenorrhea
- •BMI above 35
- •Contraindications for the use of hormonal replacement therapy
研究组 & 干预措施
Hormone replacement therapy cycle
Patients are asked to perform a blood sample, with evaluation of serum estradiol (E2), progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) on the first or second day of the menstrual cycle. If these values are considered basal for the beginning of the follicular phase, estrogen supplementation (Estradiol valerate, Progynova® 3x2mg/day) is started to induce proliferation of the endometrium. Blood sample and transvaginal ultrasound are thereafter performed ten to fourteen days later. If the endometrium is considered adequate (generally considered if triple line and above 6,5 mm thickness), embryo transfer is scheduled on the sixth day of progesterone (vaginal micronized progesterone, Utrogestan® 2x200mg twice a day) supplementation.
In case of escape spontaneous ovulation embryo transfer will be performed considering the presumable time of ovulation.
干预措施: Estradiol Valerate (Drug)
Hormone replacement therapy cycle
Patients are asked to perform a blood sample, with evaluation of serum estradiol (E2), progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) on the first or second day of the menstrual cycle. If these values are considered basal for the beginning of the follicular phase, estrogen supplementation (Estradiol valerate, Progynova® 3x2mg/day) is started to induce proliferation of the endometrium. Blood sample and transvaginal ultrasound are thereafter performed ten to fourteen days later. If the endometrium is considered adequate (generally considered if triple line and above 6,5 mm thickness), embryo transfer is scheduled on the sixth day of progesterone (vaginal micronized progesterone, Utrogestan® 2x200mg twice a day) supplementation.
In case of escape spontaneous ovulation embryo transfer will be performed considering the presumable time of ovulation.
干预措施: Micronized progesterone (Drug)
结局指标
主要结局
Miscarriage rate before 8 weeks of gestation
时间窗: 8 weeks
a spontaneous loss of a clinical pregnancy before 8 weeks of gestational age, in which the embryo(s) is/are nonviable and is/are (not) spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG
次要结局
- Miscarriage rate after 8 weeks of gestation(22 weeks)
- Clinical pregnancy rate(7 weeks)
- Ongoing pregnancy rate(20 weeks)
研究者
Caroline Roelens
Clinical fellow
CRG UZ Brussel