A Multicentre, Randomised, Double-blind, Placebo-controlled Proof of Concept Study to Compare the… (NCT00504608) | Clinical Trial Compass
CompletedPhase 1/2
A Multicentre, Randomised, Double-blind, Placebo-controlled Proof of Concept Study to Compare the Efficacy and Safety of r-hLIF (Emfilermin) for Improving Embryo Implantation Following in Vitro Fertilization (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure
150 participantsStarted 2003-04
Plain-language summary
The primary objective of the study was to provide further clinical and statistical evidence of the efficacy of r-hLIF, in comparison with placebo, administered during the luteal phase after IVF and ET for improving embryo implantation in infertile women with a history of at least 2 implantation failures following transfer of fresh embryos. The secondary objective of the study was to assess the safety profile of r-hLIF in the proposed indication.
Who can participate
Age range21 Years – 37 Years
SexFEMALE
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Inclusion criteria
✓. Pre-menopausal woman aged 21-37 years inclusive at time of consent.
✓. Infertile woman justifying IVF-ET treatment and wishing to conceive.
✓. The presence of both ovaries.
✓. Current body mass index (BMI) of ≥ 20 \& ≤ 30 kg/m2
✓. Early follicular phase (cycle day 2-5) serum FSH levels ≤ 10 IU/L. If two determinations are available, at least one should be \< 10 IU/L.
✓. History of:
✓. Normal male partner's semen analysis according to standard WHO criteria. Male partner's semen analysis must be suitable for IVF (ICSI not allowed). Donor sperm is allowed.
✓. Normal cervical cytology within 3 years prior to starting GnRH-agonist therapy.
Exclusion criteria
✕. Known to be positive for Human Immunodeficiency Virus, Hepatitis B or C Virus.
✕. History of any liver disease.
✕. Any one of the following parameters above the upper limit of normal at the prestudy visit: AST, ALT, Alkaline phosphatases, gamma GT, alpha GST, bilirubin.