Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the
      viability of the conceptus. Alterations in the peri-implantation environment are considered
      to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a
      new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single
      mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been
      recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal
      single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients
      undergoing ICSI cycles using GnRH antagonist protocol.
    

Detailed description: 
      Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the
      viability of the conceptus. There are many protocols of luteal phase support (LPS) in
      assisted reproductive technology (ART) cycles. GnRH-agonist (GnRH-a) is a new and promising
      modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the
      addition of a GnRH-a to progesterone supplementation, have been recently suggested. If the
      GnRH-a is administered in the mid-luteal phase, an initial flare-up with increased levels of
      LH takes 3-4 days before receptor down-regulation kicks in. The increased luteinizing hormone
      (LH) results in increased support for the corpus luteum (CL), leading to higher output of P4
      and providing stronger LPS. In earlier studies, the inadvertent administration of GnRH-a in
      the mid-luteal phase, did not compromise pregnancy outcomes but rather enhanced implantation
      rates. Therefore, the use of GnRH-a in LPS was investigated and found to enhance clinical
      outcomes after GnRH-a and GnRH antagonist- treated ovarian stimulation cycles, as well as, in
      recipients of donated oocytes. Several studies since then investigated the role of GnRHa for
      LPS, found that luteal support with GnRH-a could be used as the first choice in patients at
      high risk for ovarian hyperstimulation syndrome (OHSS), or even as the sole source of LPS in
      a GnRH-a-triggered antagonist ovarian stimulation cycle. Although many trials have showed
      substantial efficacy of GnRH-a addition for luteal support on pregnancy outcomes in women
      undergoing IVF/ICSI, others, found no benefit of its addition to the standard LPS. A
      meta-analysis concluded that there is benefit, however, this evidence is of very low quality.
      The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or
      multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI
      cycles using GnRH antagonist protocol.
    

Intervention name(s): gonadotropin releasing hormone-agonist; Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
Other intervention name(s): triptorelin 0.1 mg; cyclogest
Intervention MeSH terms: Triptorelin Pamoate; Hormones; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: luteal phase support, ICSI, gonadotropin releasing hormone agonist