An interventional study of cetrorelix (cetrotide) and Placebo in Ovarian Hyperstimulation Syndrome, sponsored by Eugonia. Status unknown at 1 site in Greece. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-19.
Sponsored by Eugonia · Not applicable, Interventional, and Treatment
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.
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.
64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 48 interventional studies indexed under Ovarian Hyperstimulation Syndrome.
Browse Ovarian Hyperstimulation Syndrome studies →Eugonia is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Criteria for the diagnosis of severe OHSS require:
the presence of moderate (or higher) ascites and at least two of the following:
Exclusion Criteria:
0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
Drug: cetrorelix (cetrotide)
Women with severe early OHSS will be treated with conventional treatment, such as intravenous albumin administration, paracentesis of ascitic fluid, either on an outpatient or inpatient basis.
Drug: Placebo
0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
Also known as: GnRH antagonist
intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume
Also known as: conventional treatment
Time to severe OHSS regression
Time frame: 2- 21 days after severe OHSS diagnosis
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
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Ovarian Hyperstimulation Syndrome→
Eugonia