Preventive Application of GnRH Antagonist on Early OHSS

Phase 4

• Conditions: GnRH Antagonist; Pigment Epithelium Derived Factor; Ovarian Hyperstimulation Syndrome; Vascular Endothelial Growth Factor; Aspirin
• Interventions: Drug: GnRH antagonist; Drug: aspirin

• Registration Number: NCT03188471
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-10
• Study First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 175

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.

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Exclusion Criteria

• contraindications to GnRH antagonist;
• coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
• GnRH agonist for trigger.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH antagonist	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
aspirin	aspirin	aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
vascular endothelial growth factor level	up to 1 month	VEGF level
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
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yatsen University; 🇨🇳 Guangzhou, Guangdong, China