NCT00780858

Brief Summary

Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These patients, according to recent data, have a lower pregnancy rate than controls. The possibility to avoid premature luteinization with GnRH antagonist may restore the chances of achieving a pregnancy in these women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
662

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

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

October 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

October 25, 2008

Last Update Submit

May 5, 2015

Conditions

Infertility

Keywords

GnRH antagonistIUI

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    2 weeks after intervention

Secondary Outcomes (1)

  • premature luteinization

    at the time of intervention

Study Arms (2)

Ganirelix

Patients with premature lutenization (progesterone \>1,2 ng/ml) who did not get pregnant during the first IUI underwent a second IUI.

Drug: Ganirelix

Control

Patients without premature lutenization (progesterone \>1,2 ng/ml) underwent a only one IUI.

Interventions

GanirelixDRUG

Ganirelix 0.25mg s.c every 24 h starting stimulation day 6

Also known as: Orgalutran
Ganirelix

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women with patent tubes who were undergoing IUI due to infertily of unknown origin.

You may qualify if:

  • previous failed IUI cycle with premature luteinization

You may not qualify if:

  • years or older
  • not eligible for IUI (patent tubes, \> 3 million capacitated spermatozoa)
  • previous IUI cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI-Madrid

Madrid, 28023, Spain

Location

Related Publications (1)

  • Kosmas IP, Tatsioni A, Kolibianakis EM, Verpoest W, Tournaye H, Van der Elst J, Devroey P. Effects and clinical significance of GnRH antagonist administration for IUI timing in FSH superovulated cycles: a meta-analysis. Fertil Steril. 2008 Aug;90(2):367-72. doi: 10.1016/j.fertnstert.2007.06.064. Epub 2007 Oct 23.

    PMID: 17936285BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

ganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Juan antonio García-Velasco, MD

    IVI Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 25, 2008

First Posted

October 28, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

ES(1)