NCT01005784

Brief Summary

This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2005

Typical duration 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

June 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

2.6 years

First QC Date

November 13, 2007

Last Update Submit

October 30, 2009

Conditions

Subfertility

Keywords

GnRH antagonists

Outcome Measures

Primary Outcomes (1)

  • Luteinizing hormone rise

    3-14 days (duration of ovarian stimulation)

Study Arms (2)

fixed

ACTIVE COMPARATOR
Drug: Cetrorelix (Cetrotide)

flexible

EXPERIMENTAL
Drug: Cetrorelix (Cetrotide)

Interventions

Cetrorelix (Cetrotide)DRUG

flexible antagonist administration according to specified criteria

Also known as: Cetrorelix, Cetrotide, Serono
flexible

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< 39 years of age
  • BMI 18.5-29.9
  • \<= 3 previous IVF cycles

You may not qualify if:

  • PCOS
  • Endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Human Reproduction

Thessaloniki, Greece

Location

Related Publications (1)

  • Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.

    PMID: 20637457DERIVED

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Efstratios Kolibianakis

    Unit for Human Reproduction

    PRINCIPAL INVESTIGATOR

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

November 13, 2007

First Posted

November 2, 2009

Study Start

June 1, 2005

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

GR(1)