Clinical Trial: Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36

Brief Summary: Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Incidence of moderate/severe OHSS [ Time Frame: 2-12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of each form of OHSS: mild, moderate and severe [ Time Frame: 2-13 weeks ]
  • Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol [ Time Frame: 2-13 weeks ]
  • OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification [ Time Frame: 2-13 weeks ]
  • Patients' baseline characteristics [ Time Frame: At baseline ]
  • Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation [ Time Frame: Up to 3 weeks ]
  • Description and duration of hospitalisation, treatments prescribed [ Time Frame: 2-13 weeks ]
  • Frequency and reasons for stimulation arrest and no embryo transfer decision [ Time Frame: 2-4 weeks ]
  • Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos [ Time Frame: 2-3 weeks ]
  • Description of serious and not serious adverse events [ Time Frame: 2-13 weeks ]
  • Description of patient's compliance to the prescribed treatment [ Time Frame: 2-4 weeks ]
  • Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate [ Time Frame: 4-13 weeks ]


Original Secondary Outcome: Same as current

Information By: Ferring Pharmaceuticals

Dates:
Date Received: October 3, 2012
Date Started: November 2012
Date Completion:
Last Updated: July 16, 2014
Last Verified: July 2014