Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
Condition: Infertility
MeSH terms: Infertility
Intervention: Pergoveris®; GONAL-f®; Recombinant human chorionic gonadotrophin (r-hCG)
Intervention description: Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.; GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.; On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 939.0
Sex: Female
Minimum age: 18 Years
Maximum age: 41 Years
Healthy volunteers: No
Keywords: ESPART; Reproductive Techniques, Assisted; Infertility; Pergoveris®; GONAL-f®

Summary:

      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.
    

Eligibility 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