Preventive Application of GnRH Antagonist on Early OHSS

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: GnRH antagonist
* Drug: aspirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH antagonist<br>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<br>* GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients<br>* Other names: Vitamin C platelet;|
| Active Comparator: aspirin<br>aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days. | Drug: aspirin<br>* aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days<br>* Other names: saline as placebo of GnRH antagonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of early ovarian hyperstimulation syndrome | Incidence and severity of early ovarian hyperstimulation syndrome according to its classification | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular endothelial growth factor level | VEGF level | up to 1 month | 
| pigment epithelium derived factor level | PEDF level | up to 1 month | 
| incidence of hydrothorax | one criterion for evaluation of OHSS severity | up to 1 month | 
| incidence of liver dysfunction | one criterion for evaluation of OHSS severity | up to 1 month | 
| incidence of renal dysfunction | one criterion for evaluation of OHSS severity | up to 1 month | 
| incidence of electrolytic imbalance | one criterion for evaluation of OHSS severity | up to 1 month | 
| incidence of hemoconcentration | one criterion for evaluation of OHSS severity | up to 1 month | 
| incidence of elevated WBC | one criterion for evaluation of OHSS severity | up to 1 month |