Conditions: Infertility
Keywords: In vitro fertilization Pharmacological effects of drugs Hormones Hormone Substitutes and Hormone Antagonists Pharmacological Actions Randomized Multi-center Multi-national Double-blind Active-controlled Equivalence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 397
Healthy volunteers: no

Brief summary:
Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

Detailed description:
This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.

Arms:
arm 1: Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. arm 2: Participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.

Interventions: intervention 1: corifollitropin alfa (Org 36286) intervention 2: recFSH (follitropin beta) intervention 3: gonadatropin releasing hormone (GnRH) antagonist (ganirelix) intervention 4: human chorion gonadatropin (hCG) intervention 5: progesterone intervention 6: placebo-recFSH (follitropin alfa) intervention 7: placebo-corifollitropin alfa intervention 8: open-label recFSH
Intervention descriptions: intervention 1: 100 µg corifollitropin alfa subcutaneous (SC) injection intervention 2: 150 IU recFSH SC injection intervention 3: GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day intervention 4: hCG 5,000 IU or 10,000 IU administered SC intervention 5: Progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM. intervention 6: Placebo-recFSH administered at the equivalent volume of 150 IU/day. intervention 7: Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle. intervention 8: Open-label recFSH administered up to a maximum dose of 200 IU/day.

Protocol document: