CompletedPhase 1/2

r-hLIF for Improving Embryo Implantation in IVF

50 participantsStarted 2001-09

Plain-language summary

This study was designed to obtain pilot clinical evidence of the efficacy, safety and acceptability of r-hLIF administered during the luteal phase after IVF/intra-cytoplasmic sperm injection (ICSI) and ET for improving embryo implantation in infertile women with a history of at least three implantation failures following ART. Based on LIF expression patterns and experimental data from animal research a role of LIF in embryo implantation is anticipated.

Who can participate

Age range

21 Years – 36 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 to 36 years, inclusive, at time of consent
. Infertile woman who justified IVF-ET or ICSI-ET treatment and who wished to conceive
. A history of at least three ART cycles resulting in a transfer of at least two apparently healthy embryos and no evidence of implantation menstruation and/or beta hCG \< 10 IU/L at the end of the cycle)
. Had regular ovulatory spontaneous menstrual cycles lasting 25 to 35 days
. Had FSH assessment (early follicular day 2 to 5) within the past six months \< 12 IU/L
. No other diagnosed cause of previous ART failure other than recurrent implantation failure
. A body mass index (BMI) of ³ 20 and £ 30 kg/m2, calculated according to the following formula: BMI (kg/m2) = Body Weight (kg) / Height \* Height (m2)
. The presence of both ovaries

Exclusion criteria

. Known to be positive for Human Immunodeficiency Virus
. Known to be positive for Hepatitis B or C Virus

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.

What they're measuring

Improvement of embryo implantation and Safety

Timeframe: Various

Trial details

NCT IDNCT00504530

SponsorMerck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Infertility Implantation Failure trials