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Preventive Application of GnRH Antagonist on Early OHSS

Primary Purpose

Ovarian Hyperstimulation Syndrome, GnRH Antagonist, Aspirin

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
GnRH antagonist
aspirin
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Sun Yatsen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GnRH antagonist

aspirin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence and severity of early ovarian hyperstimulation syndrome
Incidence and severity of early ovarian hyperstimulation syndrome according to its classification

Secondary Outcome Measures

vascular endothelial growth factor level
VEGF level
pigment epithelium derived factor level
PEDF level
incidence of hydrothorax
one criterion for evaluation of OHSS severity
incidence of liver dysfunction
one criterion for evaluation of OHSS severity
incidence of renal dysfunction
one criterion for evaluation of OHSS severity
incidence of electrolytic imbalance
one criterion for evaluation of OHSS severity
incidence of hemoconcentration
one criterion for evaluation of OHSS severity
incidence of elevated WBC
one criterion for evaluation of OHSS severity

Full Information

First Posted
June 10, 2017
Last Updated
June 14, 2017
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03188471
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome, GnRH Antagonist, Aspirin, Vascular Endothelial Growth Factor, Pigment Epithelium Derived Factor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRH antagonist
Arm Type
Experimental
Arm Description
Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days
Arm Title
aspirin
Arm Type
Active Comparator
Arm Description
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days.
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist
Other Intervention Name(s)
Vitamin C platelet
Intervention Description
GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
Intervention Type
Drug
Intervention Name(s)
aspirin
Other Intervention Name(s)
saline as placebo of GnRH antagonist
Intervention Description
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
Primary Outcome Measure Information:
Title
Incidence and severity of early ovarian hyperstimulation syndrome
Description
Incidence and severity of early ovarian hyperstimulation syndrome according to its classification
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
vascular endothelial growth factor level
Description
VEGF level
Time Frame
up to 1 month
Title
pigment epithelium derived factor level
Description
PEDF level
Time Frame
up to 1 month
Title
incidence of hydrothorax
Description
one criterion for evaluation of OHSS severity
Time Frame
up to 1 month
Title
incidence of liver dysfunction
Description
one criterion for evaluation of OHSS severity
Time Frame
up to 1 month
Title
incidence of renal dysfunction
Description
one criterion for evaluation of OHSS severity
Time Frame
up to 1 month
Title
incidence of electrolytic imbalance
Description
one criterion for evaluation of OHSS severity
Time Frame
up to 1 month
Title
incidence of hemoconcentration
Description
one criterion for evaluation of OHSS severity
Time Frame
up to 1 month
Title
incidence of elevated WBC
Description
one criterion for evaluation of OHSS severity
Time Frame
up to 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Canquan Zhou
Phone
+86 20 87755766
Ext
8362
Email
zhoucanquan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyun Mai
Organizational Affiliation
Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yatsen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
Email
eoshappy@163.com
First Name & Middle Initial & Last Name & Degree
Canquan Zhou

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventive Application of GnRH Antagonist on Early OHSS

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