Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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 Reference
Brief Summary: To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: corifollitropin alfa | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: corifollitropin alfa | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: corifollitropin alfa | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: Follitropin beta injection | Intervention Type: DRUG; Name: corifollitropin alfa; Assigned to Arm(s): 1, 2, 3 | Intervention Type: DRUG; Name: Follitropin beta injection; Assigned to Arm(s): 4
B: Arm Label: Experimental Group 1; Type: N/A; Interventions: Drug: Org 36286 | Arm Label: Experimental Group 2; Type: N/A; Interventions: Drug: recFSH | Intervention Type: DRUG; Name: Org 36286; Assigned to Arm(s): Experimental Group 1 | Intervention Type: DRUG; Name: recFSH; Assigned to Arm(s): Experimental Group 2
C: Arm Label: Corifollitropin alfa 100 μg; Type: N/A; Interventions: Drug: Corifollitropin alfa, Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix, Biological: human chorion gonadotropin (hCG), Biological: progesterone, Drug: placebo-recFSH (follitropin beta), Biological: open-label recFSH (follitropin beta) | Arm Label: recFSH 150 IU; Type: N/A; Interventions: Biological: recFSH (follitropin beta), Drug: gonadatropin releasing hormone (GnRH) antagonist ganirelix, Biological: human chorion gonadotropin (hCG), Biological: progesterone, Drug: placebo-corifollitropin alfa, Biological: open-label recFSH (follitropin beta) | Intervention Type: DRUG; Name: Corifollitropin alfa; Assigned to Arm(s): Corifollitropin alfa 100 μg | Intervention Type: BIOLOGICAL; Name: recFSH (follitropin beta); Assigned to Arm(s): recFSH 150 IU | Intervention Type: DRUG; Name: gonadatropin releasing hormone (GnRH) antagonist ganirelix; Assigned to Arm(s): Corifollitropin alfa 100 μg, recFSH 150 IU | Intervention Type: BIOLOGICAL; Name: human chorion gonadotropin (hCG); Assigned to Arm(s): Corifollitropin alfa 100 μg, recFSH 150 IU | Intervention Type: BIOLOGICAL; Name: progesterone; Assigned to Arm(s): Corifollitropin alfa 100 μg, recFSH 150 IU | Intervention Type: DRUG; Name: placebo-recFSH (follitropin beta); Assigned to Arm(s): Corifollitropin alfa 100 μg | Intervention Type: DRUG; Name: placebo-corifollitropin alfa; Assigned to Arm(s): recFSH 150 IU | Intervention Type: BIOLOGICAL; Name: open-label recFSH (follitropin beta); Assigned to Arm(s): Corifollitropin alfa 100 μg, recFSH 150 IU
D: Arm Label: 150 µg Corifollitropin Alfa; Type: EXPERIMENTAL; Interventions: Drug: Corifollitropin alfa, Drug: Placebo RecFSH / follitropin beta, Biological: RecFSH / Follitropin beta (Days 8 to hCG), Drug: Ganirelix, Biological: hCG, Biological: Progesterone | Arm Label: 200 IU recFSH; Type: ACTIVE_COMPARATOR; Interventions: Biological: RecFSH / Follitropin beta (Days 1 to 7), Drug: Placebo Corifollitropin alfa, Biological: RecFSH / Follitropin beta (Days 8 to hCG), Drug: Ganirelix, Biological: hCG, Biological: Progesterone | Intervention Type: DRUG; Name: Corifollitropin alfa; Assigned to Arm(s): 150 µg Corifollitropin Alfa | Intervention Type: BIOLOGICAL; Name: RecFSH / Follitropin beta (Days 1 to 7); Assigned to Arm(s): 200 IU recFSH | Intervention Type: DRUG; Name: Placebo Corifollitropin alfa; Assigned to Arm(s): 200 IU recFSH | Intervention Type: DRUG; Name: Placebo RecFSH / follitropin beta; Assigned to Arm(s): 150 µg Corifollitropin Alfa | Intervention Type: BIOLOGICAL; Name: RecFSH / Follitropin beta (Days 8 to hCG); Assigned to Arm(s): 150 µg Corifollitropin Alfa, 200 IU recFSH | Intervention Type: DRUG; Name: Ganirelix; Assigned to Arm(s): 150 µg Corifollitropin Alfa, 200 IU recFSH | Intervention Type: BIOLOGICAL; Name: hCG; Assigned to Arm(s): 150 µg Corifollitropin Alfa, 200 IU recFSH | Intervention Type: BIOLOGICAL; Name: Progesterone; Assigned to Arm(s): 150 µg Corifollitropin Alfa, 200 IU recFSH

Answer: D