A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference

A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference - Nvt

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29984

Enrollment

Registered

2006-05-02

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Infertiliteit Infertility

Interventions

Investigational group: -Org 36286: single SC injection of 150 µg (0.5 mL): day 1* -placebo-recFSH (equivalent of 200 IU fixed dose) (daily): day 1 u/i day 7 -recFSH (max 200 IU)(daily from day 8) -hCG

single SC injection of 150 µg (0.5 mL): day 1* -recFSH (SC injection 200 IU fixed dose): day 1 u/i day 7 -recFSH (max 200 IU)(daily from day 8) -hCG(5.000 or 10.000 IU/USP Units): as soon as 3 follicl

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 38819: -Females of couples with an indication for COS and IVF or ICSI; - >18 and 60 and 18 and

Exclusion criteria

Exclusion criteria: 38819: -More than 20 basal antral follicles 10 mm; visible on USS); -Presence of unilateral or bilateral hydrosalphinx (visible on USS); -Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >5 cm; -More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable); -History of non- or low ovarian response to FSH/hMG treatment; -History of recurrent miscarriage (3 or more, even when unexplained); -FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5); -Previous use of Org 36286; -Use of hormonal preparations within 1 month prior to randomization;

Design outcomes

Secondary

Measure	Time frame
38819: number of oocytes retrieved safety: ((S)AEs, occurence of moderate/severe OHSS and antibody formation)	—

Primary

Measure	Time frame
38819: pregnancy Note: 38821 (evaluation): pregnancy, mode of delivery, neonatal outcome. 38831 (evaluation): number and quality of the embryos transferred after thawing and the outcome of the FTET cycle.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)