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临床试验/NCT03763786
NCT03763786Unknown4 期

A Randomised Controlled Pilot Trial of the Use of GnRH-antagonist Pituitary Suppression During Medicated Frozen-thawed Embryo Transfer (FET) Cycles

University of Oxford1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年12月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
300
试验地点
1
主要终点
Live Birth Rate

研究概览

简要总结

The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (FET). There are several methods of preparing the patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH antagonist is administered to prevent a women's own hormones from interfering with this process as it is thought this might lead to higher numbers of cycles being cancelled. However, there is some suspicion that this drug (GnRH antagonist) may not be required and that women are using this drug unnecessarily.

Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if they have higher rates of cancelled cycles as a result.

This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone, either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find out if both give the same chance of having a baby, which treatment is better for patients and to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and well-known medication and any risk or serious adverse effects are unlikely. The study is an open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is provided by Oxford Fertility.

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

入选标准

  • Willing and able to give informed consent for participation in the study.
  • Planning to undergo medicated FET
  • Blastocyst embryo in storage available for transfer

排除标准

  • Previously randomised into the trial.
  • A history of 3 or more consecutive implantation failures (after fresh or frozen embryo transfer).
  • A history of recurrent miscarriage (3 or more consecutive miscarriages).
  • Contraindication to the use of medications for FET cycle.
  • Biopsied embryos.
  • Donor embryos or eggs (use of donor sperm is not excluded).

研究组 & 干预措施

No GnRH antaogonist

Experimental

Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days

干预措施: Cetrorelix Acetate (Drug)

Standard GnRH antoagonist

Active Comparator

Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days

干预措施: Cetrorelix Acetate (Drug)

结局指标

主要结局

Live Birth Rate

时间窗: To treatment or pregnancy end (up to 9 months)

Livebirth rate per FET treatment cycle

次要结局

  • Cancellation rate(Through study completion (18 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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