The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).
The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.
Participants who are premenopausal wishing to conceive
Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
Japanese Participants
Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
Participants with history of severe OHSS in any previous ovarian stimulation cycle
Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator