A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

Inclusion Criteria:

• Participants who are premenopausal wishing to conceive

• Participants with maximum 1 previous stimulation for assisted reproductivetechnology (ART) without pregnancy

• Japanese Participants

• Participants are women with Luteinizing hormone (LH) and Follicle stimulatinghormone (FSH) deficiency congenital or acquired

• Participants have a vaginal ultrasound scan showing both ovaries and no clinicallysignificant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary

• A semen analysis of the male partner been performed within 3 months prior tosignature of informed consent and suitable for assisted reproductive technology

• Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smearwithin 12 months of Screening. If not available, a cervical smear will be performedas part of screening

• Other protocol defined criteria may apply

Exclusion Criteria:

• Participants with history of severe OHSS in any previous ovarian stimulation cycle

• Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modifieddefinition

• Participants with contraindication to treatment with gonadotropins, hypersensitivityto gonadotropins or to any of the excipients

• Participants with presence of known or suspected gonadotropin- or estrogen dependentmalignancy (example. ovarian-, uterine-, or mammary carcinoma)

• Participants with ovarian enlargement or cyst of unknown etiology, or presence of anovarian cyst greater than 25 millimeters before Day 1

• other protocol defined exclusion criteria may apply