Infertility Implantation FailurePhase 1/2NCT00504530
r-hLIF for Improving Embryo Implantation in IVF
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
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… Read more about this study
- Who is it for?
- Ages 21 to 36 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Apr 2002
- 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 36 years
- Women only
- Adult
Who may be able to join
- 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
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- 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
- A uterine cavity without abnormalities which, in the investigator's opinion, could impair embryo implantation or pregnancy outcome, as assessed by ultrasound (US) examination performed within six months prior to beginning GnRH-agonist therapy
- Normal cervical cytology within three years prior to beginning GnRH- agonist therapy.
- At least one wash-out cycle (defined as ³ 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 beginning GnRH-agonist therapy
- Male partner semen analysis within the six months prior to starting GnRH agonist therapy
- Had a negative pregnancy test (urinary) within seven days of commencing 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
- Known to be positive for Hepatitis B or C Virus
- Known allergy to E. coli derived pharmaceutical product
- Any clinically significant systemic disease (e.g. insulin-dependant diabetes mellitus, epilepsy, severe migraine, intermittent porphyria, hepatic, renal or cardiovascular disease, severe corticosteroid-dependent asthma) or any significant allergic disease (excluding rhinitis, hay fever or sinusitis of ENT origin)
- Presence of an uncontrolled clinically significant medical condition (including infection) as determined by the investigator
- Persistent tachycardia defined as heart rate > 90 bpm confirmed by ECG
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- Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the patient in question was to be discussed with Serono's Study Director
- More than one previous failed ART cycle, where "failed" is defined as cancellation of administration of hCG due to a poor response to gonadotrophin stimulation (defined as retrieval of three oocytes or less)
- Any history of difficulties in ET procedure (i.e. requiring general anaesthetic e.g. due to position of cervix)
- Hyperprolactinaemia, defined as prolactin levels of ³ 1000 mIU/L and/or the patient remained anovulatory despite appropriate dopamine agonist treatment
- 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 was contra-indicated
- Known allergy or hypersensitivity to gonadotrophin preparations
- Known intolerance or allergy to paracetamol (acetaminophen)
- Active substance abuse
- Previous entry into this study or simultaneous participation in another clinical drug trial
About this study
Official title: A Randomised, Double-blind, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Acceptability of r-hLIF for Improving Embryo Implantation Following in Vitro Fertilisation (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure.
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.
- 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)
Secondary endpoints were implantation rate, proportion of patients with biochemical pregnancy and the 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 startSep 2001
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Brinsden, M.D., Principal investigator, Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504530
- Sponsor's protocol ID
- 23079
- Status last verified
- Dec 2016
- First submitted
- 18 Jul 2007
- Last updated
- 4 Jan 2017
- Results posted
- No
Publications
Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x.
PubMed 10987815
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 Randomised, Double-blind, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Acceptability of r-hLIF for Improving Embryo Implantation Following in Vitro Fertilisation (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure.
- ClinicalTrials.gov ID
- NCT00504530
- Acronym / sponsor ID
- 23079
- Conditions
- Infertility Implantation Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Apr 2002 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 36 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (17 listed)
- Known to be positive for Human Immunodeficiency Virus
- Known to be positive for Hepatitis B or C Virus
- Known allergy to E. coli derived pharmaceutical product
- Any clinically significant systemic disease (e.g. insulin-dependant diabetes mellitus, epilepsy, severe migraine, intermittent porphyria, hepatic, renal or cardiovascular disease, severe corticosteroid-dependent asthma) or any significant allergic disease (excluding rhinitis, hay fever or sinusitis of ENT origin)
- Presence of an uncontrolled clinically significant medical condition (including infection) as determined by the investigator
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
Secondary endpoints were implantation rate, proportion of patients with biochemical pregnancy and the 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.
- Results publication: PubMed 10987815Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x.
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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.
Peter Brinsden, 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 15 inclusion and 17 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?
On the ClinicalTrials.gov record for NCT00504530, which also lists 1 linked publication.
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.