Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.

This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.

Inclusion criteria

• Infertile adult women between 20 and 39 years at screening.
• Infertile adult women with regular menstrual cycles of 25 to 35 days at screening.
• Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening.
• If the cause of infertility is due to following reasons:

• Tubal factor
• Unknown reason
• Male infertility
• Combined factors
• Willing to give voluntary written informed consent.

Exclusion criteria

• Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities.
• Body Mass Index > 30 (BMI; kg/m2) at screening.
• Patients with a uterine (fibroids (diameter greater than or equal to 2CM endometrium), endometrial polyps, intrauterine adhesions, uterine malformations), ovaries (polycystic ovary, ovarian cysts) or adnexa (hydrosalpinx) abnormalities at screening.
• patients with uterine, ovarian surgery treatment
• Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles.
• Patients who have shown poor response with gonadotropin hormone therapy.

*At least two of the following three features must be present:

① A previous POR(≤3 retrieved oocyte with a conventional stimulation protocol)

② An abnormal ovarian reserve test (i.e. AFC < 5 follicles) at screening.

• Abnormal metrorrhagia due to unknown reason at screening.
• At least one of husband and wife to accept donor sperm or donor eggs or PGD subject
• Subjects who are positive for HIV or syphilis at screening.
• Significant known psychiatric disorder or who unable to understand the objectives and methods, etc. of this clinical trial and unable to comply with the study procedures at screening.
• Presence of elicit alcohol, smoke or drug abuse habit at screening.
• History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug.
• Participation in any other clinical trial after registering for this study or have participated in another clinical study within 3 month before randomization in this study.
• History of tumors of the ovary, breast, uterus, hypothalamus or pituary gland.
• More than 3 times previously consecutive unsuccessful in vitro fertilization cycles at screening.
• Subjects with no clomiphene citrate or gonadotropin treatment within 1 month before randomization.
• Positive serum pregnancy test at screening.
• 14 ± 2 days after the demotion, results of subjects who does not belong to the standard (antral follicle size ≥10mm)