An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation

Inclusion Criteria:

1. Subject informed consent form signed before any trial-related activities.

2. In good physical and mental health as judged by the investigator.

3. Serum anti-Müllerian hormone (AMH) levels of 15.0-35.0 pmol/L at screening (measuredat central laboratory).

4. Pre-menopausal women between the ages of 18 and 40 years. The subjects must be atleast 18 years (including the 18th birthday) and no more than 40 years (up to theday before the 41st birthday) when they sign the informed consent(s).

5. 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) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.

6. Infertility for at least 1 year before screening for subjects <35 years or for atleast 6 months for subjects ≥35 years (not applicable in case of tubal or severemale factor infertility).

7. No more than two controlled ovarian stimulation cycles initiated, regardless ofoutcome (taking exclusion criteria 2 and 3 into account) and the subject must besuitable for treatment with 10 or 15 µg/day follitropin delta (corresponding to 150or 225 IU).

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

9. Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory).

10. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (both inclusive) at screening.

Exclusion Criteria:

1. Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (AmericanSociety for Reproductive Medicine, 2012).

2. Poor response in a previous controlled ovarian stimulation cycle using agonadotropin starting dose of 150 IU/day or higher. Poor response is defined as <4oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequatefollicular development.

3. Excessive ovarian response in a previous controlled ovarian stimulation cycle forIVF/ICSI using a daily FSH/ human menopausal gonadotropin (hMG) dose of ≤225 IU,defined as ≥25 oocytes retrieved or cycle cancellation before oocyte retrieval dueto excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).

4. One or more follicles ≥10 mm (including cysts) observed on the transvaginalultrasound before randomisation on stimulation day 1 (puncture of cysts is allowedbefore randomisation).

5. Known history of recurrent miscarriage (defined as three consecutive losses afterultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).

6. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).

7. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver,or kidney) with the exception of controlled thyroid function disease.

8. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, orhypothalamus which would contraindicate the use of gonadotropins.

9. Any abnormal finding of clinical chemistry and haematology at screening or vitalsigns at randomisation, which is judged clinically relevant by the investigatorand/or requires intervention.

10. Currently breast-feeding.

11. Undiagnosed vaginal bleeding.

12. Findings at the gynaecological examination at screening which preclude gonadotropinstimulation or are associated with a reduced chance of pregnancy, e.g. congenitaluterine abnormalities or retained intrauterine device.

13. Pregnancy (negative urinary pregnancy tests must be documented at screening andbefore randomisation) or contraindication to pregnancy.

14. Use of fertility modifiers during the last menstrual cycle before start ofstimulation in the trial, including dehydroepiandrosterone (DHEA) and metformin orcycle programming with oral contraceptives, progestogen, or estrogen preparations