Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

A Phase III, Randomized, Controlled, Single-blind, Multicentre, Parallel Arm Trial to Assess the Efficacy and Safety of Pergoveris® (Follitropin Alfa and Lutropin Alfa) and GONAL-f® (Follitropin Alfa) for Multifollicular Development as Part of an Assisted Reproductive Technology Treatment Cycle in Poor Ovarian Responders, as Defined by the European Society of Human Reproduction and Embryology Criteria

This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.

Inclusion Criteria:

• Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol
• Female subjects, less than (<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
• Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
• Absence of any medical condition in which pregnancy is contraindicated
• Body mass index 18 to 30 kilogram per square meter (kg/m^2), inclusive
• Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial
• Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
• Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

• Two episodes of POR after maximal stimulation
• History or presence of tumors of the hypothalamus or pituitary gland
• History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization
• Presence of endometriosis Grade III - IV, confirmed or suspected
• Presence of uni- or bilateral hydrosalpinx
• Abnormal gynecological bleeding of undetermined origin
• Contraindication to being pregnant and/or carrying a pregnancy to term
• History or presence of ovarian, uterine or mammary cancer
• Use of testicular or epididymal sperm
• Other protocol defined exclusion criteria could apply