Preventive Application of GnRH Antagonist on Early OHSS

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

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.

Study Overview

• Status: Unknown
• Conditions: Ovarian Hyperstimulation Syndrome; GnRH Antagonist; Aspirin; Vascular Endothelial Growth Factor; Pigment Epithelium Derived Factor
• Intervention / Treatment: Drug: GnRH antagonist; Drug: aspirin

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 Type: Interventional
• Enrollment (Anticipated): 175
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Canquan Zhou; Phone Number: 8362 +86 20 87755766; Email: zhoucanquan@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yatsen University
      • Contact: Email: eoshappy@163.com
      • Principal Investigator: Canquan Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Vitamin C platelet
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: saline as placebo of GnRH antagonist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 10, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Syndrome; Ovarian Hyperstimulation Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: antagonist

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No