NCT00575302

Brief Summary

In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

4 active sites

Status
withdrawn

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

December 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 13, 2010

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

December 17, 2007

Last Update Submit

April 12, 2010

Conditions

Infertility

Keywords

IVFpoor responderrecFSHFertilization in VitroPoor responders

Outcome Measures

Primary Outcomes (1)

  • number of mature oocytes

    1 month

Secondary Outcomes (5)

  • follicular development

    1 month

  • fertilization rate

    1 month

  • implantation rate

    1 month

  • embryo quality

    1 month

  • pregnancy rate

    1 month

Study Arms (2)

300

ACTIVE COMPARATOR

administration of 300 IU Gonal-f® in a short agonist protocol.

Drug: Gonal-f®: follitropin alpha

450

EXPERIMENTAL

administration of 450 IU Gonal-f® in a short agonist protocol.

Drug: Gonal-f®: follitropin alpha

Interventions

Gonal-f®: follitropin alphaDRUG

Gonal-f®: follitropin alpha, administration of 300 U

300

Eligibility Criteria

Age38 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women \> 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
  • Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
  • Patient can be eligible for several cycles in same protocol.

You may not qualify if:

  • Patients who already received doses \> 225 IU
  • Patients older than 42 years
  • Patients with basal FSH concentrations ≥ 15 mU/ml at day 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHC Saint-Vincent

Rocourt, Liège, 4000, Belgium

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

IMEC

Brussels, 1180, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Annick Delvigne, PhD

    CHC Saint-Vincent

    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

December 17, 2007

First Posted

December 18, 2007

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 13, 2010

Record last verified: 2010-04

Locations

BE(4)