Clinical Trial: Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: GnRH Antagonist in the Luteal Phase Compared to Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) in Whom All Embryos Are Cryopres

Brief Summary: The study aims to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment in IVF patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.

Detailed Summary:

GnRH antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early OHSS, causing rapid regression of the syndrome on an outpatient basis. The approach has been described as tertiary OHSS prevention, thereby complementing the primary prevention (GnRH antagonist protocol) and secondary prevention (GnRH agonist trigger) that constitute the OHSS-free clinic concept. No randomized controlled trials (RCT) exist to date comparing luteal GnRH antagonist administration versus conventional treatment.

The aim of the present study is to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe OHSS regression, in IVF patients who develop severe early OHSS and have all their embryos cryopreserved.


Sponsor: Eugonia

Current Primary Outcome: Time to severe OHSS regression [ Time Frame: 2- 21 days after severe OHSS diagnosis ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for patient hospitalization [ Time Frame: 2- 21 days after severe OHSS diagnosis ]
  • Hematocrit levels [ Time Frame: 8 days after severe early OHSS diagnosis ]
  • White blood cells [ Time Frame: 8 days after severe early OHSS diagnosis ]
  • Diameter of ovaries [ Time Frame: 8 days after severe early OHSS diagnosis ]
  • Quantity of ascites [ Time Frame: 8 days after severe early OHSS diagnosis ]
  • Estradiol levels [ Time Frame: 8 days after severe early OHSS diagnosis ]
  • Progesterone levels [ Time Frame: 8 days after severe early OHSS diagnosis ]
  • Serum levels of vascular endothelial growth factor (VEGF) [ Time Frame: 8 days after severe early OHSS diagnosis ]


Original Secondary Outcome: Same as current

Information By: Eugonia

Dates:
Date Received: March 13, 2015
Date Started: May 2015
Date Completion: December 2016
Last Updated: March 18, 2015
Last Verified: March 2015