A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)

Inclusion Criteria:

• Signed informed consent;

• Premenopausal females, age > 18 years < 42 years

• Non-smokers. For females who were past smokers, they must have stopped tobacco usagefor at least 3 months prior screening visit

• Early follicular phase (Day 2-4) Follicle stimulating hormone (FSH) less than or equalto 15 IU/L and estradiol (E2)within normal limits at screening

• luteinizing hormone (LH), prolactin (PRL), T (testosterone) and thyroid-stimulatinghormone (TSH), within the normal limits for the clinical laboratory, or considered notclinically significant by the Investigator within 6 months prior or at screening

• Documented history of infertility (e.g., unable to conceive for at least one year orfor 6 months for women ≥ 38 years of age or bilateral tubal occlusion or absence)

• Normal transvaginal ultrasound at screening (or within 14 days prior of screening)without evidence of clinically significant abnormality consistent with findingadequate for Assisted Reproductive Technology (ART) with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)

• Subject is not pregnant , confirmed by negative pregnancy or by Investigator Judgement

• Clinically indicated protocol for induction of IVF with a fresh embryo

• Single or dual embryo transfer

• BMI ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

• Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic,hematologic/immunologic, HEENT (head, ears, eyes, nose, throat),dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine,neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevantdiseases as revealed by history, physical examination and/or laboratory assessmentswhich could limit participation in or completion of the study;

• Acute urogenital disease

• Known allergic reactions to progesterone products

• Known allergic reactions to peanuts and peanut oil

• Intake of àny experimental drug or any participation in any other clinical trialwithin 30 days prior to study start

• Mental disability or any other lack of fitness, in the Investigator's opinion, topreclude subjects to participate in or to complete the study

• Current or recent substance abuse, including alcohol and tobacco (Note: Patients whostopped tobacco usage at least 3 months prior to screening visit would be allowed)

• History of chemotherapy or radiotherapy

• Patients with more than 3 unsuccessful IVF attempts

• Contraindication for pregnancy

• Refusal or inability to comply with the requirements of the study protocol for anyreason, including scheduled clinic visits and laboratory tests

• History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriagesAcute urogenital disease