Preventive Application of GnRH Antagonist on Early OHSS

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03188471
• Other study ID #: antagonist
• Status: Recruiting
• Phase: Phase 4
• First received: June 10, 2017
• Last updated: June 14, 2017
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: June 2017
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Canquan Zhou
• Phone: +86 20 87755766
• Email: zhoucanquan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yatsen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	vascular endothelial growth factor level	VEGF level	up to 1 month
Secondary	pigment epithelium derived factor level	PEDF level	up to 1 month
Secondary	incidence of hydrothorax	one criterion for evaluation of OHSS severity	up to 1 month
Secondary	incidence of liver dysfunction	one criterion for evaluation of OHSS severity	up to 1 month
Secondary	incidence of renal dysfunction	one criterion for evaluation of OHSS severity	up to 1 month
Secondary	incidence of electrolytic imbalance	one criterion for evaluation of OHSS severity	up to 1 month
Secondary	incidence of hemoconcentration	one criterion for evaluation of OHSS severity	up to 1 month
Secondary	incidence of elevated WBC	one criterion for evaluation of OHSS severity	up to 1 month