AS900672-Enriched in Ovulation Induction

Inclusion Criteria:

1. Oligo-anovulation defined by a duration menstrual periods of 35 days to 6 months
2. Spontaneous menses or a positive response to progestin within the prior 6 months or response to clomiphene citrate evidenced by ovulation within the prior 6 months
3. Aged between 18 and 36 years, inclusive, at time of informed consent signature
4. Body mass index 18 to 30 kg/m2, inclusive
5. No clinically significant abnormalities in serum TSH, DHEA-S, prolactin, and FSH levels in the early follicular phase
6. No clinically significant abnormalities in fasting glucose and fasting insulin levels
7. Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of hysterosalpingography, laparoscopy, hysteroscopy or combination of these procedures within the prior 3 years
8. PAP smear test without clinically significant abnormalities within 6 months prior to the first screening procedure. If PAP smear was not done, it must be performed as part of screening procedures
9. Negative pregnancy test prior to randomization
10. Male partner with semen analysis demonstrating adequacy for insemination via intercourse and/or IUI within 6 months prior to the first screening procedure. If semen analysis was not done, it must be performed as part of screening procedures, (Note: Use of donor or frozen sperm is not allowed)
11. Willing and able to comply with all protocol procedures, including pregnancy and neonatal follow-up
12. Voluntary provision of written informed consent, prior to any trial-related procedure that was not part of normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to her future medical care, including willingness to provide follow-up information on babies born as part of this trial

Exclusion Criteria:

1. History of • 2 consecutive gonadotrophin stimulation cycles that did not lead to ovulation
2. History of clomiphene citrate stimulation cycles of which none lead to ovulation
3. Prior excessive response to gonadotrophin stimulation, defined as the development of •4 mature follicles (>17 mm) or cancellation of the OI cycle due to excessive follicular response after treatment with FSH at a dose of " 75 IU/day
4. Previous severe ovarian hyperstimulation syndrome (OHSS)
5. Administration of any gonadotrophin, clomiphene citrate, GnRH analogue, tamoxifen or aromatase inhibitors within 30 days prior to the screening visit
6. Laparoscopic ovarian drilling and/or ovarian cauterisation within 6 months prior to the screening visit
7. Any contraindication to pregnancy and/or to carrying pregnancy to term
8. A clinical pregnancy that ended in a miscarriage within 3 months prior to the screening visit
9. History of • 3 consecutive miscarriages, due to any cause
10. Abnormal gynaecological bleeding of undetermined origin
11. Clinically significant abnormal findings of the uterine cavity evident on a transvaginal pelvic ultrasound performed during screening
12. Presence of endometriosis, grade III - IV or requiring treatment
13. Ovarian cyst with a mean diameter of >25 mm on the day of randomization
14. History or suspicion of ovarian, uterine or mammary cancer
15. Adrenal congenital hyperplasia, partial or complete enzymatic block
16. Use of metformin or other insulin sensitising agents related to infertility within the prior 2 months
17. Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
18. Any contra-indication to gonadotrophin therapy
19. Known or suspected infection with human immunodeficiency virus (HIV), Hepatitis B or C in the trial subject or her male partner
20. Any active substance abuse or history of drug, medication or alcohol abuse within 5 years prior to the screening visit
21. Smoker consuming more than 5 cigarettes per day
22. Serum testosterone (central laboratory) that is suggestive of ovarian tumour
23. Previously randomized in this trial or participation in another investigational drug clinical trial within the prior 3 months
24. Any medical condition, which in the judgment of the Investigator may interfere with the absorption,distribution, metabolism or excretion of r-hFSH
25. Clinically significant concurrent disease (including diabetes mellitus and autoimmune diseases) that would compromise subject safety or interfere with the study assessments or clinically significant abnormal laboratory finding