Clinical trial NCT01079949 (phase 2, status: terminated)
Conditions: infertility, ovulation induction
ICD codes: N46.8, N46.9, N97.9, N97.0, N97.1, N97.2, N97.8, N92.3
Drugs: r-hlh + r-hfsh, r-hfsh, recombinant human choriogonadotropin (r-hcg), gnrh antagonist
SMILES: CC(C)C[C@H](NC(=O)[C@@H](CCCNC(N)=O)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@@H](CC1=CN=CC=C1)NC(=O)[C@@H](CC1=CC=C(Cl)C=C1)NC(=O)[C@@H](CC1=CC2=CC=CC=C2C=C1)NC(C)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Reason stopped: 
    trial was terminated due to low recruitment rate
  
Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal woman, aged 35 to 42 years wanting to become pregnant

          -  Subjects with FSH baseline plasma levels less than or equal to 10 IU/L (Day 2-5 of the
             cycle) and with LH and E2 levels within the normal limits of the local laboratory

          -  Subjects having regular spontaneous menstrual cycle lasting 25-35 days

          -  Subjects with infertility that is susceptible to treatment with IVF/ICSI

          -  Subjects to be included in a COS protocol with r-hFSH and GnRHant

          -  Subjects with partner's sperm suitable for IVF/ICSI according to local laboratory,
             unless sperm donor is to be used

          -  Subjects with both ovaries

          -  Subjects with uterine cavity capable of sustaining the implantation of embryo or
             carrying a pregnancy

          -  Subjects with normal pap smear (papanicolaou) 6 months prior to be included in the
             study (signature of informed consent)

          -  Subjects with body mass index (BMI) less than (<) 30 at the beginning of ovarian
             stimulation

          -  Subjects with confirmed absence of pregnancy with the beta-hCG test (urine or blood)
             before starting the administration of r-hFSH

          -  Subjects willing to adjust to the protocol for the entire duration of the study

          -  Subjects who have given informed consent prior to any study-related procedure that is
             not part of normal medical care

        Exclusion Criteria:

          -  Subjects or her partner with known positivity for human immunodeficiency virus (HIV)
             or Hepatitis-B /Hepatitis-C virus (HBV/HCV)

          -  Subjects with any systemic illnesses of clinical significance, hypothalamus and
             pituitary tumors; cancer of ovaries, uterus or breast; hormonal anomalies and/or
             medical, biochemical, hematological illnesses that, according to the investigator,
             could interfere with the treatment with gonadotropins

          -  Subjects with more than 2 previous ART cycles

          -  Subjects who have cancelled two previous ART cycles

          -  Subjects with frozen embryos from previous ART cycles

          -  Subjects with non-specific gynecological bleeding

          -  Subjects with ovaries that are polycystic, increased in size or with cysts of unknown
             etiology

          -  Subjects with any contraindication for becoming pregnant and/or carrying pregnancy to
             term

          -  Subjects with known allergy to gonadotropin preparations or any of the excipients

          -  Subjects with drug dependence or history of drug or alcohol abuse in the previous 5
             years

          -  Subjects who have previously entered into this study or simultaneous participation in
             another clinical drug trial with drugs

          -  Subjects who are unwilling to or not being able to adjust to the study protocol