Aspirin, GnRH Antagonist, Ovarian Hyperstimulation Syndrome, Pigment Epithelium Derived Factor, Vascular Endothelial Growth Factor
Conditions
Brief summary
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.
Detailed description
Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Early ovarian hyperstimulation syndrome (OHSS) occurs during luteal phase of controlled ovarian stimulation within 9 days after human chorionic gonadotropin trigger and reflects an acute consequence of this hormone on the ovaries.Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Recently the administration of GnRH antagonists during the luteal phase of in vitro fertilization cycles offers another therapeutic modality for patients with severe early OHSS.However, preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.
Interventions
DRUGGnRH antagonist
GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
DRUGaspirin
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* number of oocyte retrieval more than 25; * estradiol level higher than 5000pg/mL on the day of human chorionic gonadotropin administration; * clinical or ultrasonography proven ovarian hyperstimulation syndrome on the day of oocyte retrieval.
Exclusion criteria
* contraindications to GnRH antagonist; * coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied; * GnRH agonist for trigger.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of early ovarian hyperstimulation syndrome | up to 1 month | Incidence and severity of early ovarian hyperstimulation syndrome according to its classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pigment epithelium derived factor level | up to 1 month | PEDF level |
| incidence of hydrothorax | up to 1 month | one criterion for evaluation of OHSS severity |
| incidence of liver dysfunction | up to 1 month | one criterion for evaluation of OHSS severity |
| vascular endothelial growth factor level | up to 1 month | VEGF level |
| incidence of electrolytic imbalance | up to 1 month | one criterion for evaluation of OHSS severity |
| incidence of hemoconcentration | up to 1 month | one criterion for evaluation of OHSS severity |
| incidence of elevated WBC | up to 1 month | one criterion for evaluation of OHSS severity |
| incidence of renal dysfunction | up to 1 month | one criterion for evaluation of OHSS severity |
Countries
China
Contacts
Primary ContactCanquan Zhou
Outcome results
None listed