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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
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 \[mg/day\]).
Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.
Hospital de Cruces, Plaza de Cruces, 12, 48903
Vizcaya, Spain
Mean Number of Metaphase II (M-II) Oocytes Retrieved
Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.
Time frame: 36 hours post r-hCG administration
Number of Fertilized Oocytes (2 Pronuclei [2PN])
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Time frame: 36 hours post r-hCG administration
Quality of Embryos
Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. Mean number of embryos for each of the 5 grades were reported.
Time frame: Day 2-3 post r-hCG administration
Embryo Implantation Rate
Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Time frame: 35-42 days post r-hCG administration
Clinical Pregnancy Rate
Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.
Time frame: 35-42 days post r-hCG administration
Mean Number of Follicles Greater Than or Equal to (>=) 14 Millimeter (mm)
Mean number of follicles as per the following categories were presented: \>=14 mm and less than (\<) 16 mm; \>=16 mm and \<18 mm and \>=18 mm.
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Endometrial Thickness
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Number of Cycles Cancelled Due to Unsatisfactory Response
If the subject was not administered with r-hCG and withdrew prematurely from the trail, it is considered as cycle cancellation
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Mean Number of Oocytes Retrieved
Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocyte from the ovary of the female subject, enabling fertilization outside the body.
Time frame: 36 hours post r-hCG administration
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