NL-OMON32275
Completed
Phase 4
A phase IV prospective, multicentre, randomized, open-label trial to assess the efficacy and safety of GONAL f® at a dose based on subject baseline characteristics determined according to the CONSORT calculator compared with a standard dose of GONAL f® 150 IU per day for ovarian stimulation in women undergoing assisted reproductive technology (ART) - CONSORT RCT in ART
Serono0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- infertility
- Sponsor
- Serono
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be a female subject justifying an IVF/ET treatment,
- •Be between her 18th and 35th birthday (35 not included) at the time of the randomisation visit,
- •A body mass index (BMI) \< 30 kg/m2 where the BMI is calculated
- •Have early follicular phase (day 2\-4\) serum level of basal FSH £ 12 IU/L measured in the centre\*s local laboratory during the screening period (i.e. within 2 months prior to down regulation start),
Exclusion Criteria
- •Had \>\= 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as \< 5 mature follicles and/or \< 3 oocytes collected) or had \>\= 2 previous ART cycles with a hyper response (defined as ³ 25 oocytes retrieved),
Outcomes
Primary Outcomes
Not specified
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