The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology [JSOG] 2009 registry data: 24.3 percent [%]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.

Inclusion Criteria:

• Japanese race
• Woman with a history of infertility and in whom In-vitro fertilization and embryo transfer (IVF/ET) is indicated
• The controlled ovarian stimulation (COS) therapy is gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) in combination with a follicle-stimulating hormone (FSH) containing preparation
• Healthy premenopausal woman aged between 20 and 45 years (inclusive) and wishing to conceive
• Body mass index (BMI) of 17.0 to 25.0 kilogram per square meter (kg/m^2) (inclusive)
• A negative pregnancy test (urinary beta-human chorionic gonadotropin [hCG]) prior to starting COS
• Normal cervical smear result (Papanicolaou [PAP] test: Negative for Intraepithelial Lesion or Malignancy [NILM] or [Atypical Squamous Cells of Undetermined Significance {ASC-US} and Human Papillomavirus {HPV} negative]) within 12 months prior to the date of informed consent. If not available, a cervical smear and HPV test will be performed as part of Screening
• No clinically significant abnormal findings in the screening hematology, biochemistry and urinalysis parameters
• Full comprehension of the study and voluntary written informed consent obtained in writing prior to any trial-related activities

Exclusion Criteria:

• History of recurrent pregnancy loss (defined as 3 or more previous spontaneous abortions)
• History of 3 or more consecutive cancelled or failed (no clinical pregnancy) IVF/ET cycles
• Abnormal hemorrhage of the reproductive tract of undetermined origin
• Any contraindication to being pregnant and/or carrying a pregnancy to term (for example, malformations of sexual organs or fibroid tumors of the uterus incompatible with pregnancy)
• Uterine myoma requiring treatment
• Extra-uterine pregnancy within the last 3 months prior to the date of informed consent
• History or presence of intracranial tumor (for example, hypothalamic or pituitary tumor)
• Presence of or suspected gonadotropin- or estrogen-dependent malignancy (for example, ovarian, uterine or mammary carcinoma)
• Ovarian enlargement or cyst of unknown etiology
• Breast-feeding or lactation
• History of severe Ovarian Hyperstimulation Syndrome (OHSS) (Classification of OHSS Severity, as per Japan Reproductive/Endocrine Working Group)
• Known Human Immunodeficiency Virus (HIV)-positive status, or a history of or current active infection with Hepatitis B or C
• Known allergy or hypersensitivity to progesterone preparations or gonadotropin preparations and/or their excipients, or any contraindication to receive medication for controlled ovarian stimulation (for example, gonadotropin, GnRH analogues, combined oral contraceptive pill, as appropriate)
• History of or suspected alcohol or substance abuse within 5 years prior to the date of informed consent
• Clinically significant systemic disease (for example, insulin-dependent diabetes, epilepsy, severe migraine, acute porphyria, hepatic, renal or cardiovascular disease, severe corticosteroid-dependent asthma)
• Active thrombophlebitis, thromboembolic disorder or cerebral apoplexy, or a history of such conditions
• Other significant disease that in the Investigator's or Sub-Investigator's opinion would exclude the subject from the trial
• Participation in another clinical trial within 3 months prior to the date of informed consent or simultaneous participation in another clinical trial
• Legal incapacity or limited legal capacity

The study as a whole will be published prior to any individual investigator publications. It is required that copies of all papers, abstracts, articles, etc. that contain study data are to be forward to the Sponsor for review 30 days prior to submission for publication.