Infertility Implantation FailurePhase 1/2NCT00504608
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
A Phase 1/2 study testing Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF) in people with Infertility Implantation Failure, run by Merck KGaA, Darmstadt, Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 37 years, women only
- Conditions the study is for
- Infertility Implantation Failure
- What is being tested?
- Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Apr 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 37 years
- Women only
- Adult
Who may be able to join
- 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:
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- ≥ 2 ART cycles with adequate stimulation that led to the transfer of at least two or more fresh Grade A or B embryos, but did not result in implantation or
- ≥ 3ART cycles with adequate stimulation that led to the transfer of at least one fresh Grade A or B embryo from a cohort with one additional Grade A or B embryo, but did not result in implantation
- 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.
- At least one wash-out cycle (defined as ≥ 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment, prior to starting GnRH-agonist therapy.
- Negative pregnancy test within 7 days prior to starting GnRH-agonist therapy.
- Willingness and ability to comply with the protocol for the duration of the study.
- Written informed consent given prior to any study-related procedure not part of the patient's normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Who cannot join
- 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.
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- History of ART biochemical pregnancy.
- Any cause of infertility that would justify ICSI treatment
- Presence of another known cause of previous ART failure other than recurrent implantation failure.
- Uterine cavity with abnormalities which, in the investigator's opinion, could impair embryo implantation or pregnancy outcome, as assessed by US examination performed within 6 months prior to starting GnRH-agonist therapy.
- More than one previous failed ART cycle, where "failed" is defined as cancellation of administration of hCG or poor response to gonadotrophin stimulation (defined as retrieval of 3 oocytes or less).
- Any history of difficulties in ET procedure (i.e. requiring general anaesthetic e.g. due to position of cervix).
- Abnormal undiagnosed gynaecological bleeding.
- Any contraindication to being pregnant and/or carrying pregnancy to term.
- Presence of any medical condition for which the use of gonadotrophin preparations or progesterone is contra-indicated.
- Known allergy to Escherichia coli derived pharmaceutical products.
- Known allergy or hypersensitivity to gonadotrophin preparations.
- Known intolerance or allergy to paracetamol (acetaminophen).
- Active substance abuse.
- Previous LIF therapy in the same indication.
About this study
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.
- Conditions
- Infertility Implantation Failure
- Being tested
- Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of embryo implantation and safety
Measured: Various
Secondary outcomes (1)
Implantation rate, all pregnancy rateand number of live births.
Measured: Various
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startApr 2003
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Implantation FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Barrière, M.D., Principal investigator, Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504608
- Sponsor's protocol ID
- 24070
- Status last verified
- Jan 2017
- First submitted
- 18 Jul 2007
- Last updated
- 4 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00504608
- Acronym / sponsor ID
- 24070
- Conditions
- Infertility Implantation Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF) | Drug | – |
Primary outcome
Improvement of embryo implantation and safety
Time frame: Various
1 secondary outcome
Implantation rate, all pregnancy rateand number of live births.
Time frame: Various
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Barrière, M.D. principal investigator
Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF) in people with Infertility Implantation Failure, run by Merck KGaA, Darmstadt, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of embryo implantation and safety (time frame: Various). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.