A Study of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen Embryo Transfer
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer
      cycles.

      The hypothesis of the study is that the use of luteal phase support with human chorionic
      gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.
    

Detailed description: 
      Trial design:

      -A total of 450 women undergoing FET in the Centre of Assisted Reproduction and Embryology,
      The University of Hong Kong-Queen Mary Hospital, will be recruited. They will be randomized
      into one of the following two groups by computer-generated random numbers:

      Group I: luteal phase support using HCG 1500 IU intramuscular injection will be given on the
      day of FET and 6 days later.

      Group II: normal saline (placebo) intramuscular injection will be given on the day of FET and
      6 days later.

      Treatment:

      Ovarian stimulation protocol:

      All women received ovarian stimulation according to the standard protocol of the Centre. HCG
      is given intramuscularly when the leading follicle reaches 18 mm in mean diameter. Oocyte
      retrieval is carried out 36 hours after the HCG trigger. A maximum of two embryos will
      transferred and any excess good quality embryos will be frozen two days after the retrieval.

      FET cycle:

      FET is carried out at least 2 month after the stimulated cycle if the patient fails to get
      pregnant in the stimulated IVF cycle and there is at least one frozen embryo. Frozen embryos
      after thawing are transferred in natural cycles for those women having regular ovulatory
      cycles, during which the patient is monitored daily for serum estradiol ad luteinising
      hormone levels from 18 days before the expected date of the next period.

      The transfer is performed by the team clinician on the third day after the luteinising
      hormone surge and a maximum of two normally cleaving embryos are replaced according to our
      standard protocol. The luteal phase is supported as per randomization arm. Before the embryo
      transfer, the patient is interviewed by a designated research nurse who will explain the
      purpose of this study. Patients consenting to take part in the study will be assigned into
      one of the two study arms specified in an opaque envelope according to a computer-generated
      randomization list. The envelope will be read and injection (HCG or placebo as normal saline)
      given by a service nurse not involved in the study. Blood will be taken on day 6 after FET
      before the patient receives the second dose of HCG or placebo. A urine pregnancy test will be
      performed 16 days after the FET. In case of pregnancy, the outcome of pregnancy will be
      traced afterwards and used for analysis. Luteal phase support is not continued in those who
      get pregnant.
    

Intervention name(s): Human chorionic gonadotrophin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.; Normal saline intramuscularly on the day of embryo transfer and 5 days after embryo transfer.
Other intervention name(s): Normal saline
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Luteal phase support; Human chorionic gonadotrophin; frozen-thawed embryo transfer cycle