Clinical trial NCT03188471: Preventive Application of GnRH Antagonist on Early OHSS
Official title: Preventive Application of GnRH Antagonist on Early Ovarian Hyperstimulation Syndrome in High-risk Women: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ovarian Hyperstimulation Syndrome
GnRH Antagonist
Aspirin
Vascular Endothelial Growth Factor
Pigment Epithelium Derived Factor
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence and severity of early ovarian hyperstimulation syndrome
timeFrame: up to 1 month
Secondary outcomes:
measure: vascular endothelial growth factor level
timeFrame: up to 1 month
measure: pigment epithelium derived factor level
timeFrame: up to 1 month
measure: incidence of hydrothorax
timeFrame: up to 1 month
measure: incidence of liver dysfunction
timeFrame: up to 1 month
measure: incidence of renal dysfunction
timeFrame: up to 1 month
measure: incidence of electrolytic imbalance
timeFrame: up to 1 month
measure: incidence of hemoconcentration
timeFrame: up to 1 month
measure: incidence of elevated WBC
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yatsen University
state: Guangdong
Study officials:
affiliation: Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University
name: Qingyun Mai
role: PRINCIPAL_INVESTIGATOR
References: