Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel

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