Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
Centre Hospitalier Chretien
Collaborator:
EMD Serono
Information provided by:
Centre Hospitalier Chretien
ClinicalTrials.gov Identifier:
NCT00575302
First received: December 17, 2007
Last updated: April 12, 2010
Last verified: April 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Gonal-f®: follitropin alpha |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Chretien:
Primary Outcome Measures:
- number of mature oocytes [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- follicular development [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- fertilization rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- implantation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- embryo quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- pregnancy rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 38 Years to 42 Years |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Annick Delvigne, CHC Saint-Vincent |
| ClinicalTrials.gov Identifier: | NCT00575302 History of Changes |
| Other Study ID Numbers: | Study 300 versus 450 |
| Study First Received: | December 17, 2007 |
| Last Updated: | April 12, 2010 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013