Endometrial Preparation With Aromatase Inhibitors Versus Estradiol in Frozen Embryo Transfer Cycles
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- clinical pregnancy
研究概览
简要总结
Comparison of protocols for frozen embryo transfer (ET): One protocol using Estrogen supplements and the second protocol using Letrozole
详细描述
Study design. Randomized control trial will be conducted at the IVF Units at Meir Medical Center.
Participants. Patients undergoing frozen embryo transfer (ET) cycle with single blastocyst transfer.
Outcome measures The primary outcome measure is clinical pregnancy rate defined as intrauterine pregnancy with positive fetal heart beat measured 2-3 weeks after positive β-hCG test. Secondary outcome measures include: pregnancy rate (defined as positive beta-hCG test 12-14 days after embryo transfer), implantation rate and miscarriage rate.
Methods.
Patients who are candidates for vitrified-warmed single blastocyst transfer will be recruited for the study after signing informed consent form. Patients will then be randomized to one of the following groups:
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing frozen embryo transfer cycle
- •Single blastocyst transfer
- •Normal uterine cavity.
- •Exclusion criteria:
- •Woman age older than 40
- •Cleavage stage embryo
- •More than 3 previous transfers w/o pregnancy
- •Oocyte donation cycle.
排除标准
- 未提供
研究组 & 干预措施
Estrogen
Endometrial preparation: Estrogen supplements (Estradiol 6mg/d) will be started at the 2nd-3rd day of the cycle. First US scan will be performed after 10 days. If necessary, adjusting the estradiol doses will be performed according to the physician decision. After achieving trilinear endometrial thickness ≥8mm progesterone supplements (Endometrin 100mg*3/d) will be administrated. Embryo transfer will be performed after completing 5 days of progesterone supplements (at the 6th day after starting the progesterone supplements).
干预措施: endometrial preparation for frozen blastocyst transfer (Procedure)
Estrogen
Endometrial preparation: Estrogen supplements (Estradiol 6mg/d) will be started at the 2nd-3rd day of the cycle. First US scan will be performed after 10 days. If necessary, adjusting the estradiol doses will be performed according to the physician decision. After achieving trilinear endometrial thickness ≥8mm progesterone supplements (Endometrin 100mg*3/d) will be administrated. Embryo transfer will be performed after completing 5 days of progesterone supplements (at the 6th day after starting the progesterone supplements).
干预措施: Estrofem (Drug)
Estrogen
Endometrial preparation: Estrogen supplements (Estradiol 6mg/d) will be started at the 2nd-3rd day of the cycle. First US scan will be performed after 10 days. If necessary, adjusting the estradiol doses will be performed according to the physician decision. After achieving trilinear endometrial thickness ≥8mm progesterone supplements (Endometrin 100mg*3/d) will be administrated. Embryo transfer will be performed after completing 5 days of progesterone supplements (at the 6th day after starting the progesterone supplements).
干预措施: Endometrin 100Mg Vaginal Insert (Drug)
Letrozole
Women in the Letrozole arm will be treated with Aromatase inhibitors ( Letrozole; 2.5 mg per day) starting at the 3rd day of the cycle for 5 days. US scan,and blood work for serum Estradiol (E2) and progesterone (P) will initially be examined 3-5 days after the last Letrozole pill. Following US scans and serum E2+P will be performed according to the treating physician decision. When US scan demonstrate trilaminar endometrium ≥8 mm and the dominant follicle will be ≥18mm, hCG will be administrated ( recommbinant hCG - Ovitrelle 250 mcg) and 3 days later vaginal Endometrin 100mg*3/d will be started. Single vitrified-warmed blastocyst transfer will be performed after completing 4 days of the progesterone supplements (7 days from hCG administration).
干预措施: endometrial preparation for frozen blastocyst transfer (Procedure)
Letrozole
Women in the Letrozole arm will be treated with Aromatase inhibitors ( Letrozole; 2.5 mg per day) starting at the 3rd day of the cycle for 5 days. US scan,and blood work for serum Estradiol (E2) and progesterone (P) will initially be examined 3-5 days after the last Letrozole pill. Following US scans and serum E2+P will be performed according to the treating physician decision. When US scan demonstrate trilaminar endometrium ≥8 mm and the dominant follicle will be ≥18mm, hCG will be administrated ( recommbinant hCG - Ovitrelle 250 mcg) and 3 days later vaginal Endometrin 100mg*3/d will be started. Single vitrified-warmed blastocyst transfer will be performed after completing 4 days of the progesterone supplements (7 days from hCG administration).
干预措施: Letrozole (Drug)
Letrozole
Women in the Letrozole arm will be treated with Aromatase inhibitors ( Letrozole; 2.5 mg per day) starting at the 3rd day of the cycle for 5 days. US scan,and blood work for serum Estradiol (E2) and progesterone (P) will initially be examined 3-5 days after the last Letrozole pill. Following US scans and serum E2+P will be performed according to the treating physician decision. When US scan demonstrate trilaminar endometrium ≥8 mm and the dominant follicle will be ≥18mm, hCG will be administrated ( recommbinant hCG - Ovitrelle 250 mcg) and 3 days later vaginal Endometrin 100mg*3/d will be started. Single vitrified-warmed blastocyst transfer will be performed after completing 4 days of the progesterone supplements (7 days from hCG administration).
干预措施: Ovidrel (Drug)
Letrozole
Women in the Letrozole arm will be treated with Aromatase inhibitors ( Letrozole; 2.5 mg per day) starting at the 3rd day of the cycle for 5 days. US scan,and blood work for serum Estradiol (E2) and progesterone (P) will initially be examined 3-5 days after the last Letrozole pill. Following US scans and serum E2+P will be performed according to the treating physician decision. When US scan demonstrate trilaminar endometrium ≥8 mm and the dominant follicle will be ≥18mm, hCG will be administrated ( recommbinant hCG - Ovitrelle 250 mcg) and 3 days later vaginal Endometrin 100mg*3/d will be started. Single vitrified-warmed blastocyst transfer will be performed after completing 4 days of the progesterone supplements (7 days from hCG administration).
干预措施: Endometrin 100Mg Vaginal Insert (Drug)
结局指标
主要结局
clinical pregnancy
时间窗: 4 to 5 weeks after the embryo transfer ( 6-7 weeks of pregnancy).
The primary outcome measure is clinical pregnancy rate defines as intrauterine pregnancy with positive fetal heart beat measure 2-3 weeks after positive β-hCG TEST ( 6-7 weeks of pregnancy)
次要结局
- pregnancy rate(12-14 days after the embryo transfer)