Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Condition: Infertility
MeSH terms: Infertility
Intervention: Forielle
Intervention description: Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Maximum age: 41 Years
Healthy volunteers: No
Keywords: Infertility; Forielle; Assisted Reproductive Technique (ART); Controlled Ovarian Stimulation (COS)

Summary:

      This is a multicenter, prospective randomized controlled, interventional investigation to
      assess the safety and clinical performance of Forielle, a medical device for endometrial
      washing, in restoring favorable endometrial condition to implantation after Controlled
      Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All infertile women treated with intracytoplasmic sperm injection (ICSI)/Fertilization
             in Vitro and Embryo Transfer (FIVET)

          -  Less than or equal to (<=) 1 previous failed embryo transfer

          -  Eumenorrheic normo-gonadotropic women

          -  Basal follicle-stimulating hormone (FSH) <=12 International unit per liter (IU/L)

          -  Anti-mullerian hormone (AMH) greater than (>) 1.1 nanogram per milliliter (ng/mL)

          -  Ovarian Reserve: number of antral follicles 2 millimeter (mm) between 6 <= antral
             follicle count (AFC) <= 16

          -  Follicles > 16 mm at the triggering day between 5-14

          -  Body Mass Index (BMI) between 18 <= BMI <= 27 kilogram per meter square (kg/m^2)

          -  Indication for Fresh Embryo transfer

          -  Normal uterine cavity on ultrasound exam (e.g., no presence of hydrosalpinx)

          -  Undergoing Assisted Reproductive Technique (ART) and oocyte maturation by human
             chorionic gonadotropin (HCG) triggering

          -  Progesterone (P4) serum level at the HCG triggering day <= 1.5 ng/mL (Day
             O/Randomization)

          -  Estradiol (E2) <= 3000 picogram/milliliter (pg/mL) at the human chorionic gonadotropin
             (HCG) triggering day (Day 0/Randomization)

          -  Subjects must have read and signed the Informed Consent Form prior to
             study-specific-procedures not part of standard of care

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Clinically significant systemic disease (such as diabetes, metabolic syndrome,
             immunological diseases, diagnosed thrombophilia, porphyria, or any other medical
             condition requiring the use of low-molecular weight heparin therapy)

          -  Polycystic ovary syndrome (PCOS) according to Rotterdam Consensus Criteria (European
             Society of Human Reproduction and Embryology [ESHRE]/American Society for Reproductive
             Medicine [ASRM], 2003)

          -  Poor ovarian response (POR) according to the European Society of Human Reproduction
             and Embryology (ESHRE) Criteria

          -  RIF (repeated implantation failure), defined as greater than or equals to (>=) 2
             previous failed embryo transfers

          -  Endometriosis III-IV stage or adenomyosis

          -  Clinically significant findings on exam or ultrasound, such as salpingitis,
             hydrosalpynx or evidence of ovarian cysts

          -  Known hypersensitivity to any of the components of the solution

          -  Known hypersensitivity to vaginal progesterone or its excipients

          -  Other protocol defined exclusion criteria could apply