NL-OMON32275CompletedPhase 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 enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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),
Investigators
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