NCT03188471

Preventive Application of GnRH Antagonist on Early OHSS

Preventive Application of GnRH Antagonist on Early Ovarian Hyperstimulation Syndrome in High-risk Women: A Prospective Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Hyperstimulation Syndrome
• GnRH Antagonist
• Aspirin
• Vascular Endothelial Growth Factor
• Pigment Epithelium Derived Factor

Interventions

Type	Name	Description
DRUG	GnRH antagonist	GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
DRUG	aspirin	aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2017-06-15
• Last updated: 2017-06-15

Locations

1 site across 1 country: China