Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-range Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation in a Long GnRH Agonist Protocol
Brief Summary: The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist protocol.

Furthermore, the study intends:

* To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol.
* To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.
* To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.


Options:
A: Inclusion Criteria:

* All patients referred for infertility receiving their first IVF or IVF+ICSI treatment

Exclusion Criteria:

* Previous IVF or IVF+ICSI-treatment
* Uterine anomalies
* It is necessary to perform direct sperm aspiration from husband's/partner's testicles
* Allergy to one of the intervention products
* Patient is 40 years or above
B: Inclusion Criteria:

* Informed consent documents signed prior to screening evaluations.
* In good physical and mental health as judged by the investigator.
* Anti-Müllerian hormone (AMH) levels at screening of 5.0-35.0 pmol/L (as measured by Elecsys® AMH Plus Immunoassay \[Roche Diagnostics\] at central laboratory).
* Pre-menopausal women between the ages of 30 and 42 years. The subjects must be at least 30 years (including the 30th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent.
* 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 and/or intracytoplasmic sperm injection using fresh or frozen ejaculated sperm from male partner or sperm donor.
* Infertility for at least 1 year before screening for subjects less than 35 years or for at least 6 months for subjects greater than equal to (≥)35 years (not applicable in case of tubal or severe male factor infertility).

Exclusion Criteria:

* Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (defined by the revised American Society for Reproductive Medicine \[ASRM\] classification, 1996).
* One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound after down-regulation prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation).
* Pregnancy (negative pregnancy tests must be documented at screening and prior to start of down-regulation) or contraindication to pregnancy.
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:

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

Answer: B