NCT00461422

Brief Summary

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 27, 2008

Status Verified

June 1, 2008

Enrollment Period

3.4 years

First QC Date

April 17, 2007

Last Update Submit

June 26, 2008

Conditions

InfertilityIVF Treatment

Keywords

IVFGnRH antagonist

Outcome Measures

Primary Outcomes (1)

  • pregnancy rates

    one cycle

Secondary Outcomes (5)

  • differences in hormonal levels

    one cycle

  • differences in the basic treatment doses

    one cycle

  • oocyte counts

    one cycle

  • fertilization rate

    one cycle

  • cleavage rate

    one cycle

Study Arms (2)

1

EXPERIMENTAL

Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle

Drug: Ganirelix

2

NO INTERVENTION

Standard Flexible antagonist protocol

Interventions

GanirelixDRUG

sc injection of Ganirelix 0.25 mg per day

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • infertility
  • IVF candidate
  • failure of previous IVF attempt

You may not qualify if:

  • low ovarian reserve
  • untreated distortion of uterine cavity
  • medical contraindication for IVF treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Baruch Padeh medical center, Poriya

Tiberias, 15208, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

ganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Yohnny S Younis, MD

    The Ministry of Health, Israel

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

January 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 27, 2008

Record last verified: 2008-06

Locations

IL(1)