NCT02461875

Brief Summary

The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.

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
236

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

May 29, 2015

Last Update Submit

November 15, 2015

Conditions

OHSS

Keywords

OHSSInfertilityCabergolineGnRH antagonistIVF-ET

Outcome Measures

Primary Outcomes (1)

  • Moderate or severe ovarian hyperstimulation syndrome

    Within 4 weeks of HCG adminstration

Secondary Outcomes (1)

  • The Number of Participants Who Achieved Ongoing Pregnancy

    18 weeks after embryo transfer

Study Arms (2)

Cabergoline group

ACTIVE COMPARATOR

Cabergoline is administered starting on the day of HCG administration.

Drug: Cabergoline

GnRH antagonist rescue & cabergoline group

EXPERIMENTAL

Converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) and Cabergoline is administered starting on the day of HCG administration.

Drug: GnRH antagonist rescue & cabergoline

Interventions

CabergolineDRUG

Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.

Cabergoline group
GnRH antagonist rescue & cabergolineDRUG

when the leading follicle reaches 16 mm, HP-uFSH is continued at daily dose of 75 IU/day till the day of HCG administration. Moreover, Gn RH agonist (triptorelin) is discontinued and GnRH antagonist (Cetrorelix acetate)0.25 mg S.C is administered daily till the day of HCG administration. Serum estradiol is measured daily and HCG (5,000 IU/I.M) is administered when serum estradiol level drops below 3500 pg/ml . Moreover, cabergoline 0.5 mg p.o is administered at bed time for 8 days starting on the day of HCG administration.

GnRH antagonist rescue & cabergoline group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol and at high risk of developing OHSS \[ have more than 20 follicles ( 90% of them less than 14 mm in mean diameter) and serum estradiol ≥ 3000 pg/ml\]

You may not qualify if:

  • Fibrosis of lung,
  • swelling or inflammation around the heart or lung,
  • hypertension,
  • liver disease,
  • heart valve disease and
  • allergy to cabergoline or ergot derivatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera( Al Gazeera) hospital

Giza, Giza Governorate, Egypt

RECRUITING

Related Publications (2)

  • Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9. doi: 10.1016/s1472-6483(10)60339-2.

    PMID: 17854523BACKGROUND

  • Fouda UM, Sayed AM, Elshaer HS, Hammad BE, Shaban MM, Elsetohy KA, Youssef MA. GnRH antagonist rescue protocol combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome: a randomized controlled trial. J Ovarian Res. 2016 May 17;9(1):29. doi: 10.1186/s13048-016-0237-8.

    PMID: 27184139DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Usama M Fouda, M.D,PhD

    Aljazeera (Al Gazeera) hospital

    STUDY CHAIR

Central Study Contacts

Usama M Fouda, M.D,PhD

CONTACT

01095401375umfrfouda@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D , PhD

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 3, 2015

Study Start

May 1, 2013

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

EG(1)