Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this work is to study the value of GnRH antagonist subcutaneous administration as
      an alternative to coasting in prevention of severe OHSS and its impact on embryos quality &
      the outcome of ICSI.
    

Detailed description: 
      Infertility affects up to one in seven couples all over the world. In vitro
      fertilization-embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) are
      commonly used in the management of infertility attributable to tubal factor, significant
      endometriosis, male factor and also persistent unexplained infertility. Recruitment and
      development of multiple follicles in response to gonadotrophin stimulation are necessary for
      successful assisted reproduction. In young ovulating women undergoing IVF treatment, the
      standard stimulation protocol can result in either poor response or ovarian hyperstimulation
      syndrome (OHSS).

      OHSS is a serious and potentially life-threatening iatrogenic complication of controlled
      ovarian hyperstimulation (COH) which may cause serious impact on patient's health. OHSS is
      the most feared complication of IVF-related ovarian stimulation, which in its severe form
      leads to hospitalization and in the worst case scenario fatal complications. As many as 33%
      of IVF cycles have been reported to be associated with mild forms of OHSS. The incidence of
      moderate OHSS is estimated to be between 3% and 6%, while the severe form may occur in 0.1-3%
      of all cycles. Among high risk women the incidence approaches 20%.

      Development of multiple follicles forms the basis of OHSS. Exogenous human chorionic
      gonadotrophin (hCG) administration for the final maturation of oocytes or endogenous
      production of hCG after pregnancy is the second factor needed for the development of severe
      OHSS. Severe OHSS is characterized by massive ovarian enlargement, pleural effusion, ascites,
      oliguria, hemoconcentration, and thromboembolic phenomena. Coasting is described as a
      withholding therapy while continuing with releasing hormone agonist/antagonist
      administration, until safe levels of estradiol (E2) are attained. GnRH antagonists causes an
      immediate suppression of E2 levels and therefore could prevent OHSS in GnRH antagonist
      cycles. A comparison between coasting and GnRH antagonist administration in women at high
      risk of OHSS during ovarian stimulation for IVF with GnRH agonist long protocol, in the hope
      of preventing the drawbacks of prolonged coasting.
    

Intervention name(s): Gonadotropin; Antagonist
Intervention type(s): Drug; Drug
Intervention description(s): withholding gonadotropin administration for at least 24 hours; Cetrorelix acetate 0.25 mg
Other intervention name(s): Cetrorelix acetate
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention