Prospective Randomized Control Study of Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of the study is to compare the pregnancy rate between women treated with Gonadotropin Releasing Hormone (GnRH) agonist together with Human Chorionic Gonadotropin (HCG) and standard luteal support with progesterone following transfer of frozen embryos in in-vitro-fertilization (IVF) natural cycles.
详细描述
The rate of frozen embryos transfer (FET) has increased in recent years due to a higher tendency of single embryo transfer, use of preimplantation genetic testing, and prevention of ovarian hyperstimulation.
There are different methods to prepare the endometrium for FET:
- Natural cycle (NC) - natural preparation of the body for implantation without the need for medicinal intervention.
- Modified natural cycle (mNC) - Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger.
- Medical - preparation of endometrium with hormones (estrogen and progesterone).
Following embryo transfer, luteal phase support should be considered. Administration of treatment depends on the type of cycle chosen (either natural or medicated). Treatment options include progesterone, HCG and Gonadotropin Releasing Hormone (GnRH) analog - either one of them or combined. Different protocols (dosages and duration of use) with different pregnancy outcomes were explore before with inconclusive results. We wish to investigate administration of GnRH agonist+HCG vs. progesterone.
Patients included in the study will be women undergoing natural cycle FET at the IVF center in Shaare Zedek, Jerusalem, Israel. All patients will be randomly divided into two groups, each will receive a different luteal treatment support as will be detailed later. Patients demographic data and pregnancy outcomes will be collected.
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 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normo-ovulatory women
- •Women undergoing frozen embryos transfer in a natural cycle
- •Age 18-45
- •BMI 18-35
排除标准
- •Women undergoing medicated frozen embryos transfer
- •Women with a BMI over 35 or under
- •Women with hydrosalpinges
- •Women with defects or uterine malformations (congenital) or acquired such as myomas
- •Egg donation and surrogacy
- •Use of preimplantation genetic testing
研究组 & 干预措施
Study group
Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol:
Cleavage stage embryo:
- ET day (embryo day 2-3) - Ovitrelle 125mcg
- Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg
- Day 6 after ET- Ovitrelle 125mcg
- Day 9 after ET - Ovitrelle 125mcg
Embryo blastocyst stage:
- ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg
- Day 3 after ET - Ovitrelle 125mcg
- Day 6 after ET - Ovitrelle 125mcg
干预措施: GnRH agonist (Drug)
Study group
Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol:
Cleavage stage embryo:
- ET day (embryo day 2-3) - Ovitrelle 125mcg
- Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg
- Day 6 after ET- Ovitrelle 125mcg
- Day 9 after ET - Ovitrelle 125mcg
Embryo blastocyst stage:
- ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg
- Day 3 after ET - Ovitrelle 125mcg
- Day 6 after ET - Ovitrelle 125mcg
干预措施: hCG (Drug)
Control group
Patients will receive luteal support with vaginal progesterone - 100 mg Endometrin twice daily until week 8 of pregnancy.
干预措施: Progesterone 100Mg Vag Tab (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: up to two month after embryo transfer
visualization of intrauterine gestational sac on ultrasound divided by number of transfers
次要结局
- Overall pregnancy rate(up to two month after embryo transfer)
- Live birth rate(up to 42 weeks after embryo transfer)
- Implantation rate(up to two month after embryo transfer)
- Ectopic pregnancy rate(up to two month after embryo transfer)
- Miscarriage rate(up to 20 weeks after embryo transfer)
研究者
Heli Alexandroni
Alexandroni Heli
Shaare Zedek Medical Center
