Conditions: Infertility Ovulation Induction
Keywords: Reproductive technology, Assisted Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH) Ovulation induction Infertility
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

Brief summary:
This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Recombinant human follicle stimulating hormone (r-hFSH) intervention 2: Recombinant human luteinizing hormone (r-hLH)
Intervention descriptions: intervention 1: Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]). intervention 2: Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.

Protocol document: