- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504530
r-hLIF for Improving Embryo Implantation in IVF
January 3, 2017 updated by: Merck KGaA, Darmstadt, Germany
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 36 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
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
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of embryo implantation and Safety
Time Frame: Various
|
Various
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary endpoints were implantation rate, proportion of patients with biochemical pregnancy and the number of live births.
Time Frame: various
|
various
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Brinsden, M.D., Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Study Completion (Actual)
April 1, 2002
Study Registration Dates
First Submitted
July 18, 2007
First Submitted That Met QC Criteria
July 18, 2007
First Posted (Estimate)
July 20, 2007
Study Record Updates
Last Update Posted (Estimate)
January 4, 2017
Last Update Submitted That Met QC Criteria
January 3, 2017
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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