Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
Brief Summary: This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.


Options:
A: Inclusion Criteria:

1. Female subjects justifying an in-vitro fertilization (IVF)/embryo transfer (ET) treatment
2. Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
3. Between her 18th and 35th birthday (35 not included) at the time of the randomization visit
4. Body mass index (BMI) lower than 30 kilogram per square meter (kg/m\^2) where the BMI is calculated according to the formula
5. Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
6. Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal to 12 International Unit per Liter (IU/L) measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start)
7. Presence of both ovaries
8. Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy
9. Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to randomization
10. Have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy
11. Willing and able to comply with the protocol for the duration of the trial
12. Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care

Exclusion Criteria:

1. Have greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or lower than or equal to 3 oocytes collected) or have greater than or equal to 2 previous ART cycles with a hyper response (defined as greater than or equal to 25 oocytes retrieved)
2. Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible
3. Have previous severe ovarian hyperstimulation syndrome (OHSS)
4. Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
5. Presence of endometriosis requiring treatment
6. Uterine myoma requiring treatment
7. Any contraindication to being pregnant and/or carrying a pregnancy to term
8. Extra-uterine pregnancy within the last 3 months prior to screening
9. History of 3 or more miscarriages (early or late miscarriages) due to any cause
10. Tumors of the hypothalamus and pituitary gland
11. Ovarian enlargement or cyst of unknown etiology
12. Ovarian, uterine or mammary cancer
13. A clinically significant systemic disease
14. Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,
15. Abnormal gynecological bleeding of undetermined origin
16. Known allergy or hypersensitivity to human gonadotrophin preparations,
17. Any active substance abuse or history of drug medication or alcohol abuse in the past 5 years prior to the screening visit
18. Entered previously into this trial or simultaneous participation in another clinical trial
B: Inclusion Criteria:

* Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
* Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
* Women aged 18-37 years
* Women with body mass index (BMI) of 18.5-32.0 kg/m2

Exclusion Criteria:

* Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
* Women with history of recurrent miscarriage
* Women with contraindications to controlled ovarian stimulation with gonadotropins
* Women with three or more controlled ovarian stimulation cycles
C: Inclusion criteria:

* Informed Consent Documents signed prior to screening evaluations
* In good physical and mental health
* Pre-menopausal females 21-34 years of age
* Body mass index (BMI)18-25 kg/m2
* Eligible for intracytoplasmic sperm injection (ICSI)
* Unexplained infertility or partner with mild male factor infertility
* Infertility for at least 12 months before randomization
* Regular menstrual cycles of 24-35 days, presumed to be ovulatory
* Hysterosalpingography, hysteroscopy, or transvaginal ultrasound documenting a uterus consistent with expected normal function
* Transvaginal ultrasound documenting expected normal function of the ovaries
* Early follicular phase serum levels of FSH between 1 and 12 IU/L
* Early follicular phase total antral follicle (diameter 2-10 mm) count ≥ 10 for both ovaries combined
* Willing to accept transfer of one blastocyst in the fresh cycle
* Willing to undergo frozen embryo replacement cycles with transfer of one blastocyst per cycle within the first year after randomisation

Exclusion criteria:

* Known polycystic ovarian syndrome or known endometriosis stage I-IV
* Diagnosed as "poor responder" in a previous controlled ovarian stimulation (COS) cycle
* Severe ovarian hyperstimulation syndrome (OHSS)in a previous COS cycle
* History of recurrent miscarriage
* Current or past (12 months prior to randomization) abuse of alcohol or drugs, and/or current (last month) intake of more than 14 units of alcohol per week
* Current or past smoking habit of more than 10 cigarettes per day
* Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial
* Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue
* Previous participation in the trial
* Use of any non registered investigational drugs during 3 months before randomization
D: Inclusion Criteria:

* RESIDENT OF CANADA
* Premenopausal
* Age 40 years or less at the time of enrollment
* At risk of a poor ovarian response defined as: either \<5 oocytes or \<8 follicles in a previous cycle, FSH \> 10 IU/L, AMH \< 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
* Primary infertility or secondary
* Not previously undertaken a cycle that was included in this study

Exclusion Criteria:

* Simultaneous participation in another clinical trial
* Body mass index (BMI) \> 38 kg/m2
* Early follicular phase (day 2-4) serum FSH level \> 20 mIU/ml
* Any contraindication to being pregnant and carrying a pregnancy to term
* Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
* Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
* Administration of any investigational drugs within three months prior to study enrollment
* Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
* Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
* Unwillingness to give written informed consent

Answer: B