Clinical trial NCT00696878
Conditions: In Vitro Fertilization
Keywords: Infertility Pharmacological effects of drugs Hormones, Hormone Substitutes and Hormone Antagonists Pharmacological Actions Multi-center
Sponsor: Organon and Co
Start date: 2006-09-26; Completion date: 2009-05-15
Enrollment: 682 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.

Detailed description:
This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The trial period per participant will cover 1, 2 or 3 COS treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed Embryo Transfer (FTET) cycles following either or both of the first two treatment cycles. In each stimulation cycle, participants receive a single injection of corifollitropin alfa and one week later, treatment is continued with a daily dose of any FSH-containing preparation up to the day of (rec)hCG administration for final oocyte maturation. Assessment of anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection are important safety endpoints in this trial.

Arms: arm 1: Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Administration of (rec)hCG occurred when 3 follicles ≥17 mm were observed on ultrasound scan (USS). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone for luteal phase support was administered starting on the day of oocyte pick-up (34-36 hours after \[rec\]hCG) and continued for approximately 6 weeks. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur.
Interventions: intervention 1: Corifollitropin alfa intervention 2: FSH intervention 3: GnRH antagonist intervention 4: (rec)hCG intervention 5: Progesterone
Intervention descriptions: intervention 1: Corifollitropin alfa 150 µg administered as a single subcutaneous dose. intervention 2: FSH administerd subcutaneously at a dose not to exceed 225 IU/day. intervention 3: GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day. intervention 4: (rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg. intervention 5: Progesterone administered vaginally at a dose of at least 600 mg/day.

Protocol documents: