A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age
Condition: Infertility; Ovulation Induction
MeSH terms: Infertility
Intervention: Recombinant human luteinizing hormone (rhLH); Recombinant follicle-stimulating hormone (rFSH)
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Infertility; Ovulation induction; Luveris; Controlled ovarian stimulation; Reproductive technologies, assisted

Summary:

      This is a multicentric, open, randomized, comparative trial aimed to assess the influence of
      recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation
      (COS) in advanced reproductive age in terms of improved embryo competence which allows to
      transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy
      rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal female subject aged greater than (>) 35 years

          -  Subjects with baseline FSH serum level less than or equal to (<=) 10 IU/liter (l), LH
             and E2 levels within local normal range and plasma prolactin levels < 30
             nanogram/milliliter (ng/ml)

          -  Subjects with regular spontaneous menstrual cycles of 25-35 days

          -  Subjects with infertility justifying IVF/ICSI-ET treatment

          -  Subjects programmed for COS with r-FSH under GnRH agonist protocol

          -  Sperm from current male partner suitable for IVF/ICSI according to local lab, unless
             sperm donor is foreseen

          -  Subjects with presence of both ovaries

          -  Subjects whose uterine cavity is able to sustain embryo implantation or pregnancy

          -  Subjects with normal papanicolaou test (PAP) smear within previous 3 years

          -  Subjects with body mass index (BMI) < 30 at stimulation start

          -  Subjects who receive confirmation of not being pregnant by a negative beta-hCG test
             (urine or blood) prior to starting r-FSH administration

          -  Subjects willing and able to comply with the protocol for the duration of the study

          -  Subjects who have given informed consent prior to any study-related procedure not part
             of normal medical care

        Exclusion Criteria:

          -  Subjects or her male partners who are known to be human immunodeficiency virus,
             hepatitis B virus or hepatitis C virus positive

          -  Subjects with any clinically significant systemic disease; tumors of the hypothalamus
             and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or
             medical, biochemical, hematological condition which in the judgment of the
             investigator may interfere with gonadotropin treatment

          -  Subjects with more than 2 previous assisted reproductive technologies (ART) cycles

          -  Subjects in which previous cycles were cancelled due to poor response (< 3 antral
             follicles after 15 day of stimulation)

          -  Subjects with cryopreserved embryos from previous ART cycles

          -  Subjects with unexplained gynecological bleeding

          -  Subjects with polycystic ovaries, ovarian enlargement or cyst of unknown etiology

          -  Subjects known to have any contraindication to being pregnant and/or carrying
             pregnancy to term

          -  Subjects with known allergy to gonadotrophin preparations or any of the excipients

          -  Subjects known to have any active substance abuse or history of drug, medication or
             alcohol abuse in the past 5 years

          -  Subjects with previous entry into this study or simultaneous participation in another
             clinical drug trial

          -  Subjects who have refused to or inability to comply with the protocol