Preventive Application of GnRH Antagonist on Early OHSS
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
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
Other Names:
|
| Active Comparator: aspirin aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days. |
Drug: aspirin
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 renal 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
Eligibility Criteria
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:
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contraindications to GnRH antagonist;
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coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
-
GnRH agonist for trigger.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Sun Yatsen University | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
Investigators
- Principal Investigator: Qingyun Mai, Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- antagonist