A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 Μg or 15 Μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

Inclusion Criteria:

• Signed and dated Informed Consent Form for participation in the trial, obtainedbefore any trial-related procedures.

• In good physical and mental health in the judgement of the investigator.

• Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40years (up to the day before the 41st birthday) at the time of randomisation.

• Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IUGONAL-F, as judged by the investigator.

• Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.

• Infertile women diagnosed with tubal infertility, unexplained infertility,endometriosis stage I/II or with partners diagnosed with male factor infertility,eligible for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI)using fresh or frozen ejaculated sperm from male partner or sperm donor

• Infertility for at least one year before randomisation for subjects <35 years or forat least 6 months for subjects ≥35 years (criteria not applicable in case of tubalor severe male factor infertility).

• Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.

• Transvaginal ultrasound documenting presence and adequate visualisation of bothovaries, without evidence of significant abnormality. Both ovaries must beaccessible for oocyte retrieval.

• Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior torandomisation).

• Serum anti-Müllerian hormone (AMH) concentration of ≤35 pmol/L at screening.

Exclusion Criteria:

• Primary ovarian failure.

• More than three previous controlled ovarian stimulation cycles initiated, regardlessof outcome.

• History of previous episode of OHSS, exuberant ovarian response to gonadotropins, orpolycystic ovarian syndrome.

• Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver orkidney) which can compromise participation in the trial with the exception ofcontrolled thyroid function disease.

• Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamuswhich would contraindicate the use of gonadotropins.

• Fibroid tumours of the uterus incompatible with pregnancy.

• Currently breast-feeding.

• Known inherited or acquired thrombophilia disease.

• Active arterial or venous thromboembolism or severe thrombophlebitis, or a historyof these events.

• Known porphyria.