A Phase 3 interventional study of GnRH antagonist (Cetrorelix) and Placebo (saline solution) in Ovarian Hyperstimulation Syndrome, Effects of Gonadotropin and Oocyte Maturation, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-19.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 3, Interventional, and Treatment
The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.
Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).
66 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 50 interventional studies indexed under Ovarian Hyperstimulation Syndrome.
Browse Ovarian Hyperstimulation Syndrome studies →Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
• GnRH antagonist (Cetrorelix 0.25)
Drug: GnRH antagonist (Cetrorelix)
• Placebo (saline solution)
Drug: Placebo (saline solution)
•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval
• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval
Ultrasound
Ultrasound measurements: ascitis and ovarian size
Time frame: one week
Blood measurements
Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.
Time frame: one week
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gonadotropin Releasing Hormone Antagonist
Ovarian Hyperstimulation Syndrome →
Instituto Valenciano de Infertilidad, IVI VALENCIA