Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a prospective randomized clinical controlled trial to assess the efficacy of
      the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro
      fertilization (IVF) cycles.
    

Detailed description: 
      Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation
      which might be life threatening in the severe forms. Since there is still no definite cure
      for this syndrome, prevention is considered as an essential and vital issue. The objective of
      this study is to determine the effect of Methylprednisolone to prevent ovarian hyper
      stimulation syndrome in IVF cycles.

      The study population comprises all infertile patients with diagnosis of polycystic ovarian
      syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized
      based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea,
      hyper androgynism (clinical or laboratory), LH/FSH>2 and ovarian morphological evidences in
      Doppler ultrasound.

      The existence of more than 20 follicles in both ovaries and E2 concentration >4000 pg/ml will
      be considered as the OHSS risk factors.

      In this study all eligible patients will be randomly allocated into two study groups by a
      computerized randomization method:

      Treatment group (case) will be administered 16 mg Methylprednisolone initiated from the first
      day of stimulation and will be tapered after the first pregnancy test (day 13 after the
      embryo transfer). Furthermore, these patients will receive a bolus IV dose
      methylprednisolone, 1g on the day of egg collection and embryo transfer.

      Patients in the control group will not receive any treatment with glucocorticoids. If each
      group confronts with every kind of high risk signs or symptoms, they will undergo coasting or
      gonadotropin withdrawal or other treatment strategies.

      The presence of OHSS is defined in accordance with the Golan 5 grade system and women who at
      least are at grade 2 of this classification (Mild) considered as OHSS cases and will
      experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and
      enlargement of ovaries(5-12cm). In Moderate forms, ultrasound evidences of ascites will be
      observed and severe OHSS accompany with clinical signs of ascites, hydrothorax, breathing
      disorders, hemoconcentration, coagulopathy and renal perfusion decrease.
    

Intervention name(s): Methylprednisolone; Control
Intervention type(s): Drug; Drug
Intervention description(s): Administration of Methylprednisolone; Normal salin injection
Other intervention name(s): Case
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ovarian hyper stimulation syndrome; Methylprednisolone; IVF