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Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

Primary Purpose

Infertility

Status
Withdrawn
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha
Sponsored by
Centre Hospitalier Chretien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, poor responder, recFSH, Fertilization in Vitro, Poor responders

Eligibility Criteria

38 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • CHC Saint-Vincent
  • CHU Saint-Pierre
  • IMEC
  • UZ Gent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

300

450

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of mature oocytes

Secondary Outcome Measures

follicular development
fertilization rate
implantation rate
embryo quality
pregnancy rate

Full Information

First Posted
December 17, 2007
Last Updated
April 12, 2010
Sponsor
Centre Hospitalier Chretien
Collaborators
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT00575302
Brief Title
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Official Title
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Withdrawn
Why Stopped
36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Chretien
Collaborators
EMD Serono

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups: 300 IU versus 450 IU of Gonal-f® administered in a short 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, poor responder, recFSH, Fertilization in Vitro, Poor responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
300
Arm Type
Active Comparator
Arm Description
administration of 300 IU Gonal-f® in a short agonist protocol.
Arm Title
450
Arm Type
Experimental
Arm Description
administration of 450 IU Gonal-f® in a short agonist protocol.
Intervention Type
Drug
Intervention Name(s)
Gonal-f®: follitropin alpha
Intervention Description
Gonal-f®: follitropin alpha, administration of 300 U
Intervention Type
Drug
Intervention Name(s)
Gonal-f®: follitropin alpha
Intervention Description
Gonal-f®: follitropin alpha, administration of 450 U
Primary Outcome Measure Information:
Title
number of mature oocytes
Time Frame
1 month
Secondary Outcome Measure Information:
Title
follicular development
Time Frame
1 month
Title
fertilization rate
Time Frame
1 month
Title
implantation rate
Time Frame
1 month
Title
embryo quality
Time Frame
1 month
Title
pregnancy rate
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients who already received doses > 225 IU Patients older than 42 years Patients with basal FSH concentrations ≥ 15 mU/ml at day 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annick Delvigne, PhD
Organizational Affiliation
CHC Saint-Vincent
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHC Saint-Vincent
City
Rocourt
State/Province
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
IMEC
City
Brussels
ZIP/Postal Code
1180
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

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