NCT01347268

Brief Summary

Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction and is a life threatening iatrogenic complication. In patients with GnRH agonist protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated with a reduction in (E2) levels with subsequent decreasing the incidence and severity of OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe 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
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

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, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 4, 2011

Status Verified

January 1, 2011

Enrollment Period

1.4 years

First QC Date

April 26, 2011

Last Update Submit

May 2, 2011

Conditions

In Vitro Fertilization

Keywords

coastingwithdrawing GnRH agonistGnRH antagonistIVF

Outcome Measures

Primary Outcomes (2)

  • decreased levels of estradiol (E2)

    one year

  • The days of coasting

    The interval between the day of starting intervention and the day of hCG administration

    one year

Secondary Outcomes (3)

  • number of oocytes retrieved

    one year

  • pregnancy rate

    one year

  • the incidencess of OHSS

    one year

Study Arms (2)

withdrawing GnRH agonists

EXPERIMENTAL
Procedure: withdrawing GnRH agonists

GnRH antagonist administration

EXPERIMENTAL
Procedure: GnRH antagonist

Interventions

GnRH antagonistPROCEDURE

GnRH antagonist administration and continued low dose r-FSH 75 IU

GnRH antagonist administration
withdrawing GnRH agonistsPROCEDURE

withdrawing GnRH agonists and continued low dose r-FSH 75 IU

withdrawing GnRH agonists

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the risk of ovarian hyperstimulation syndrome

You may not qualify if:

  • allergic to GnRH antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

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

Study Officials

  • Jiann-Loung Hwang, MD

    Shin-Kong Wu Ho-Su Memerial Hospital

    STUDY CHAIR

Central Study Contacts

Jiann-Loung Hwang, MD

CONTACT

886-2-28332211m001015@ms.skh.org.tw

Heng-Ju Chen, MD

CONTACT

886-2-28332211m004983@ms.skh.org.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

May 4, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

May 4, 2011

Record last verified: 2011-01

Locations

TW(1)