A Phase 4 interventional study of GnRH antagonist and aspirin in Ovarian Hyperstimulation Syndrome, GnRH Antagonist and Aspirin, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-06-15.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Phase 4, Interventional, and Prevention
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.
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.
64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.
This study's planned enrollment of 175 is above the median of 100 across 48 interventional studies indexed under Ovarian Hyperstimulation Syndrome.
Browse Ovarian Hyperstimulation Syndrome studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days
Drug: GnRH antagonist
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days.
Drug: aspirin
GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
Also known as: Vitamin C platelet
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
Also known as: saline as placebo of GnRH antagonist
Incidence and severity of early ovarian hyperstimulation syndrome
Incidence and severity of early ovarian hyperstimulation syndrome according to its classification
Time frame: up to 1 month
vascular endothelial growth factor level
VEGF level
Time frame: up to 1 month
pigment epithelium derived factor level
PEDF level
Time frame: up to 1 month
incidence of hydrothorax
one criterion for evaluation of OHSS severity
Time frame: up to 1 month
incidence of liver dysfunction
one criterion for evaluation of OHSS severity
Time frame: up to 1 month
incidence of renal dysfunction
one criterion for evaluation of OHSS severity
Time frame: up to 1 month
incidence of electrolytic imbalance
one criterion for evaluation of OHSS severity
Time frame: up to 1 month
incidence of hemoconcentration
one criterion for evaluation of OHSS severity
Time frame: up to 1 month
incidence of elevated WBC
one criterion for evaluation of OHSS severity
Time frame: up to 1 month
Plan to share: No
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This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Ovarian Hyperstimulation Syndrome→
First Affiliated Hospital, Sun Yat-Sen University