A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

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 baseline visit

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

• 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 to 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 of screening) withoutevidence of clinically significant abnormality consistent with finding adequate forAssisted Reproductive Technology (ART) with respect to uterus and adnexa (nohydrosalpinx or clinically relevant uterine fibroids)

• Negative pregnancy test on the day of pituitary down regulation (prior toadministration of gonadotropin releasing hormones (GnRH) agonist or GnRH antagonist)

• 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, head, ears, eyes, nose, throat (HEENT),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 experimental drug or participation in any other clinical trial within 30days 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 miscarriages