A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age

Launched by MERCK KGAA, DARMSTADT, GERMANY · Mar 2, 2010

Keywords

ClinConnect Summary

Preclinical pharmacology studies have demonstrated that r-hLH has a LH/human chorionic gonadotropin (hCG) receptor affinity similar to pituitary human luteinizing hormone (p-hLH), and is biologically active in-vitro in stimulating steroidogenesis and in promoting oocyte germinal vesicle breakdown. Several clinical studies have investigated the usefulness of r-hLH supplementation in normal ovulatory women undergoing ART and in almost all of them sub-populations of subjects have been identified who will benefit, when r-hLH is added to FSH.

OBJECTIVES

Primary objectives:

* To determine the ...

Gender

FEMALE

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