Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of cabergoline in
      prevention of ovarian hyperstimulation syndrome versus albumin in ART program.
    

Detailed description: 
      Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic potentially life threatening
      complication of assisted reproduction technologies due to gonadotropin and human chorionic
      gonadotropin administration. Its severe form has been reported in 1-10% of in vitro
      fertilization cycles.

      Different strategies have been proposed for the prevention of OHSS in high-risk patients, but
      these approaches do not offer complete protection against the development of ovarian
      hyperstimulation syndrome (OHSS). Among the selected preventive methods, discontinuing
      (coasting) gonadotropin therapy and i.v. albumin were by far the most popular choices.
      Several previous studies have shown that cabergoline is a safe drug, both for mother and
      conceptus, for the treatment of macroadenoma hyperprolactinemia. We think that this kind of
      therapy may be safe both for mother and conceptus (as previously shown by several studies on
      dopamine agonists treatment of hyperprolactinemia during pregnancy), easier, cheaper and
      probably, more effective than previous OHSS treatments (albumin, steroids, dopamine). There
      is an urgent need to test cabergoline efficacy in OHSS prevention in high risk patients with
      a large multicenter study.

      The proposal of This study approved by our institutional review boards and institution's
      ethical committee, and all Participants will sign a written consent before enter to study.
      Patients entering the intracytoplasmic sperm injection (ICSI) / IVF program in Royan
      institute and infertility research center in Valieasr hospital in Iran. We use a
      downregulation protocol with a GnRH agonist (buserelin acetate) as a long protocol for ICSI/
      IVF-ET. We evaluate patients for high risk factors of severe OHSS. The inclusion criterion
      was the collection of >20 oocytes during oocyte retrieval. They allocate by a series of
      computer-generated random into two groups after the oocytes retrieval. 30 minutes after
      oocytes retrieval patients in A Group , receive human albumin 20% infusion and in B group
      receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval then women in
      all groups will informed about the signs and symptoms of OHSS and counsel to contact with our
      institute if OHSS develops. Patients will monitor routinely 6days after ET by
      ultrasonographic examination for ovarian size and for detection of ascites. Moderate to
      severe OHSS patients hospitalize and evaluate routinely by haematological and biochemical
      tests. OHSS patients diagnose and classify according to Golan et al 1989.we compare incidence
      of OHSS and severity of OHSS patients in two groups. Pregnant patients follow until the 12th
      gestational week.
    

Intervention name(s): Cabergoline; Control
Intervention type(s): Drug; Drug
Intervention description(s): Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval; Receive human albumin 20% infusion
Other intervention name(s): B; A
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: OHSS