Ovarian Hyperstimulation Syndrome
Conditions
Keywords
severe OHSS, antagonist administration, conventional treatment
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 description
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.
Interventions
0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
DRUGPlacebo
intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume
Sponsors
Eugonia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with established severe early OHSS. * Criteria for the diagnosis of severe OHSS require: * the presence of moderate (or higher) ascites and at least two of the following: * enlarged ovaries (\>100 mm maximal diameter), * haematocrit (Ht) \>45%, * white blood cell count (WBC) \>15,000/mm3.
Exclusion criteria
* Women not fulfilling the above criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to severe OHSS regression | 2- 21 days after severe OHSS diagnosis |
Secondary
| Measure | Time frame |
|---|---|
| Hematocrit levels | 8 days after severe early OHSS diagnosis |
| White blood cells | 8 days after severe early OHSS diagnosis |
| Diameter of ovaries | 8 days after severe early OHSS diagnosis |
| Need for patient hospitalization | 2- 21 days after severe OHSS diagnosis |
| Estradiol levels | 8 days after severe early OHSS diagnosis |
| Progesterone levels | 8 days after severe early OHSS diagnosis |
| Serum levels of vascular endothelial growth factor (VEGF) | 8 days after severe early OHSS diagnosis |
| Quantity of ascites | 8 days after severe early OHSS diagnosis |
Countries
Greece
Contacts
Primary ContactGeorge T Lainas, PhD
Backup ContactTrifon G Lainas, PhD
Outcome results
None listed