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 range
21 Years – 37 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Any clinically significant systemic disease.
. Any significant allergic disease.
. Presence of an uncontrolled clinically significant medical condition including infection) as determined by the investigator.
. History of ART biochemical pregnancy.
. Any cause of infertility that would justify ICSI treatment