Infertility Clinical Trial
Official title:
A Phase III, Multicentre, Open-label Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone (Luveris) With r-hFSH on Follicular Development in Women Undergoing Ovarian Stimulation for ART
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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