A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies
Condition: Infertility; Ovarian Stimulation
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the
      uterine cavity has become a well established treatment for female infertility attributable to
      damaged fallopian tubes, endometriosis or unexplained causes where alternative forms of
      therapy have failed. The most commonly used protocols of follicular stimulation now employs
      follicle stimulating hormone (FSH) and long-acting agonists of gonadotropin releasing hormone
      (GnRH) to prevent the occurrence of a mid-cycle luteinizing hormone (LH) surge and to ensure
      the induction of well-synchronized larger cohort of ovarian follicles.

      The results of a number of studies have demonstrated that in the majority of clinical
      situations, FSH administration alone is sufficient to achieve successful follicular
      development. A study had shown that in subjects receiving recombinant human-follicle
      stimulating hormone (r-hFSH) and recombinant human-luteinizing hormone (r-hLH), pregnancy
      rates were similar in the younger and older age groups, however, in women receiving r-hFSH
      alone, there was a significant decline in pregnancy rates for women 35 and older. This
      particular study also went on to show that the subgroup of women 35 and older, may benefit
      from supplementary r-hLH. A number of studies have been conducted to assess the safety and
      efficacy of r-hLH administered concomitantly with r-hFSH in the presence of developing
      follicles to reduce the rate of growth of intermediate and small follicles while allowing the
      dominant follicle to continue to progress.

      This was a Phase III, open-label, multicentre study to evaluate safety and efficacy of
      addition of Recombinant Human-Luteinizing Hormone (Luveris) to a standard assisted
      reproductive technologies (ART) protocol.
    

Detailed description: 
      Luteinizing hormone is a heterodimeric glycoprotein composed of a non-covalent association of
      an α and a β subunit. Prior to the generation of human-LH (hLH) through recombinant
      technology, hLH had only been available for therapeutic use as human menopausal gonadotropins
      (hMG), a co-extracted, purified preparation of hLH and hFSH from urine of post menopausal
      women. Recombinant Human-Luteinizing Hormone (Luveris) has been found to be well tolerated in
      human pharmacokinetic and pharmacodynamic studies at doses of up to 40,000 IU in healthy
      female volunteers without any Serious Adverse Event (SAE) experience being reported.

      OBJECTIVES

        -  To evaluate safety and efficacy of addition of Recombinant Human-Luteinizing Hormone
           (Luveris) to a standard ART procedure.

      In this study, subjects were first treated with a GnRH agonist to induce pituitary
      desensitization according to centre's standard practice followed by administration of r-hFSH.
      All subjects were then treated with Recombinant Human -Luteinizing Hormone (Luveris)150 IU
      per day subcutaneous (s.c.) from Day 6 of stimulation of their ART treatment cycle,
      continuing at the same dose until injection of hCG upto and including day of last FSH dose.
    

Intervention name(s): Recombinant Human-Luteinizing Hormone (Luveris)
Intervention type(s): Drug
Intervention description(s): Recombinant Human-Luteinizing Hormone (Luveris) was administered once daily subcutaneously at a starting dose of 150 IU per day beginning on stimulation Day 6.
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Ovarian Stimulation; Luveris; Lutropin alpha; Controlled ovarian stimulation; Reproductive techniques, assisted