NCT03188471

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 10, 2017

Last Update Submit

June 14, 2017

Conditions

Ovarian Hyperstimulation SyndromeGnRH AntagonistAspirinVascular Endothelial Growth FactorPigment Epithelium Derived Factor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • vascular endothelial growth factor level

    up to 1 month

  • pigment epithelium derived factor level

    up to 1 month

  • incidence of hydrothorax

    up to 1 month

  • incidence of liver dysfunction

    up to 1 month

  • incidence of renal dysfunction

    up to 1 month

  • +3 more secondary outcomes

Study Arms (2)

GnRH antagonist

EXPERIMENTAL

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

aspirin

ACTIVE COMPARATOR

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

Drug: aspirin

Interventions

GnRH antagonistDRUG

GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients

Also known as: Vitamin C platelet
GnRH antagonist
aspirinDRUG

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

Also known as: saline as placebo of GnRH antagonist
aspirin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • contraindications to GnRH antagonist;
  • coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;
  • GnRH agonist for trigger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yatsen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-AspirinSodium Chloride

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Qingyun Mai

    Center for Reproductive Medicine and Department of Gynecology & Obstetrics, First Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Canquan Zhou

CONTACT

+86 20 87755766zhoucanquan@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Center for Reproductive Medicine and Department of Gynecology & Obstetrics

Study Record Dates

First Submitted

June 10, 2017

First Posted

June 15, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)