Preventive Application of GnRH Antagonist on Early OHSS

Sun Yat-sen University

Status and phase: Unknown; Phase 4

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

Treatments: Drug: aspirin; Drug: GnRH antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT03188471

antagonist

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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175 participants in 2 patient groups

GnRH antagonist

Experimental group

Description:

Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days

Treatment:

Drug: GnRH antagonist

aspirin

Active Comparator group

Description:

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

Treatment:

Drug: aspirin