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

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ClinicalTrials.gov Identifier: NCT00575302
Recruitment Status : Withdrawn (36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical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.)
First Posted : December 18, 2007
Last Update Posted : April 13, 2010
Sponsor:
Collaborator:
EMD Serono
Information provided by:
Centre Hospitalier Chretien

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Gonal-f®: follitropin alpha Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Study Start Date : December 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: 300
administration of 300 IU Gonal-f® in a short agonist protocol.
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 300 U
Experimental: 450
administration of 450 IU Gonal-f® in a short agonist protocol.
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 450 U



Primary Outcome Measures :
  1. number of mature oocytes [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. follicular development [ Time Frame: 1 month ]
  2. fertilization rate [ Time Frame: 1 month ]
  3. implantation rate [ Time Frame: 1 month ]
  4. embryo quality [ Time Frame: 1 month ]
  5. pregnancy rate [ Time Frame: 1 month ]


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Ages Eligible for Study:   38 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575302


Locations
Belgium
CHC Saint-Vincent
Rocourt, Liège, Belgium, 4000
CHU Saint-Pierre
Brussels, Belgium, 1000
IMEC
Brussels, Belgium, 1180
UZ Gent
Gent, Belgium, 9000
Sponsors and Collaborators
Centre Hospitalier Chretien
EMD Serono
Investigators
Principal Investigator: Annick Delvigne, PhD CHC Saint-Vincent

Responsible Party: Annick Delvigne, CHC Saint-Vincent
ClinicalTrials.gov Identifier: NCT00575302     History of Changes
Other Study ID Numbers: Study 300 versus 450
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010

Keywords provided by Centre Hospitalier Chretien:
IVF
poor responder
recFSH
Fertilization in Vitro
Poor responders

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs