Preventive Application of GnRH Antagonist on Early Ovarian Hyperstimulation Syndrome in High-risk Women: A Prospective Randomized Trial
Overview
- Phase
- Phase 4
- Intervention
- GnRH antagonist
- Conditions
- Ovarian Hyperstimulation Syndrome
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Incidence and severity of early ovarian hyperstimulation syndrome
- Last Updated
- 8 years ago
Overview
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.
Investigators
Zhou Canquan
Chief of the Center for Reproductive Medicine and Department of Gynecology & Obstetrics
First Affiliated Hospital, Sun Yat-Sen University
Eligibility Criteria
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.
Arms & Interventions
GnRH antagonist
Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days
Intervention: GnRH antagonist
aspirin
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days.
Intervention: aspirin
Outcomes
Primary Outcomes
Incidence and severity of early ovarian hyperstimulation syndrome
Time Frame: up to 1 month
Incidence and severity of early ovarian hyperstimulation syndrome according to its classification
Secondary Outcomes
- vascular endothelial growth factor level(up to 1 month)
- pigment epithelium derived factor level(up to 1 month)
- incidence of hydrothorax(up to 1 month)
- incidence of liver dysfunction(up to 1 month)
- incidence of electrolytic imbalance(up to 1 month)
- incidence of hemoconcentration(up to 1 month)
- incidence of elevated WBC(up to 1 month)
- incidence of renal dysfunction(up to 1 month)