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A phase III, multicenter, randomized, open, comparative study to evaluate if the addition of r-hLH (Luveris) ti FSH from day 8 of ovarian stimulation is able to decrease total FSH dose and to improve cycle outcome in infertile women undergoing ART, who required high FSH dose in a previous cycle.

A phase III, multicenter, randomized, open, comparative study to evaluate if the addition of r-hLH (Luveris) ti FSH from day 8 of ovarian stimulation is able to decrease total FSH dose and to improve cycle outcome in infertile women undergoing ART, who required high FSH dose in a previous cycle.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002218-13-IT
Enrollment
250
Registered
2005-09-20
Start date
2004-11-09
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Reduction of the FSH dose needed to obtain/retrieve each oocyte after administration of Luveris to FSH at day 8 of ovarian stimulation. MedDRA version: 6.1 Level: PT Classification code 10021928

Interventions

Trade Name: LUVERIS*SC 1 FL 75 UI + 1 FL Product Name: NA Product Code: NA Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Lutropin alfa CAS Number: 152923-57-4

Sponsors

INDUSTRIA FARMACEUTICA SERONO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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