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Prospective, randomized trial to evaluate the administration of 2 different doses of recombinant FSH to patients with age depended insufficient ovarian response during IVF/ICSI

Prospective, randomized trial to evaluate the administration of 2 different doses of recombinant FSH to patients with age depended insufficient ovarian response during IVF/ICSI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006443-50-BE
Enrollment
Unknown
Registered
2007-11-21
Start date
2007-12-12
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with age dependend insufficient ovarian response during IVF/ICSI

Interventions

Trade Name: Gonal-f Product Name: Gonal-f Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: follitropine alfa CAS Number: 9002-68-0 Concentration unit: IU interna

Sponsors

University Hospital Ghent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Women > 38 years, who had insufficient response to stimulation with regular (for that age) posology of 225 IU of gonadotrophins (urinary or recombinant), in a short agonist protocol in a previous cycle Insufficient response is defined as: development of or = 16 mm) at time of hCG administration. - Patient can be eligible for several cycles in the same protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients who received already doses > 225 IU, whatever the outcome was - Patients older than 43 years - Patients with basal FSH concentrations > or = 15 mU/ml at Day 3

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the usefulness of exceeding the usual daily doses of 225 IU administered to women above 38 years, more in particular to compare the standard maximal dose of 300 IU Gonal-F per day with a higher dose of 450 IU per day. ;Secondary Objective: ;Primary end point(s): - Implantation rate per embryo transfer - Pregnancy rate (clinical pregnancy) - Life births - Number of oocytes retrieved - Number of mature oocytes (metaphase II oocytes) - Fertilization rate - Embryo quality—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026