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临床试验/NCT05838105
NCT05838105招募中不适用

Prospective Randomized Control Study of Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物

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:

  1. Natural cycle (NC) - natural preparation of the body for implantation without the need for medicinal intervention.
  2. Modified natural cycle (mNC) - Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger.
  3. 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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heli Alexandroni

Alexandroni Heli

Shaare Zedek Medical Center

研究点 (1)

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