r-hLIF for Improving Embryo Implantation in IVF

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00504530
First received: July 18, 2007
Last updated: February 17, 2014
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Infertility, Implantation Failure.
Drug: Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Improvement of embryo implantation and Safety [ Time Frame: Various ]

Secondary Outcome Measures:
  • Secondary endpoints were implantation rate, proportion of patients with biochemical pregnancy and the number of live births. [ Time Frame: various ]

Enrollment: 50
Study Start Date: September 2001
Study Completion Date: April 2002
  Eligibility

Ages Eligible for Study:   21 Years to 36 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  1. Pre-menopausal woman aged 21 to 36 years, inclusive, at time of consent
  2. Infertile woman who justified IVF-ET or ICSI-ET treatment and who wished to conceive
  3. 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)
  4. Had regular ovulatory spontaneous menstrual cycles lasting 25 to 35 days
  5. Had FSH assessment (early follicular day 2 to 5) within the past six months < 12 IU/L
  6. No other diagnosed cause of previous ART failure other than recurrent implantation failure
  7. 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)
  8. The presence of both ovaries
  9. 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
  10. Normal cervical cytology within three years prior to beginning GnRH- agonist therapy.
  11. 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
  12. Male partner semen analysis within the six months prior to starting GnRH agonist therapy
  13. Had a negative pregnancy test (urinary) within seven days of commencing GnRH-agonist therapy.
  14. Willingness and ability to comply with the protocol for the duration of the study
  15. 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:

  1. Known to be positive for Human Immunodeficiency Virus
  2. Known to be positive for Hepatitis B or C Virus
  3. Known allergy to E. coli derived pharmaceutical product
  4. 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)
  5. Presence of an uncontrolled clinically significant medical condition (including infection) as determined by the investigator
  6. Persistent tachycardia defined as heart rate > 90 bpm confirmed by ECG
  7. 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
  8. 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)
  9. Any history of difficulties in ET procedure (i.e. requiring general anaesthetic e.g. due to position of cervix)
  10. Hyperprolactinaemia, defined as prolactin levels of ³ 1000 mIU/L and/or the patient remained anovulatory despite appropriate dopamine agonist treatment
  11. Abnormal undiagnosed gynaecological bleeding
  12. Any contraindication to being pregnant and/or carrying pregnancy to term
  13. Presence of any medical condition for which the use of gonadotrophin preparations or progesterone was contra-indicated
  14. Known allergy or hypersensitivity to gonadotrophin preparations
  15. Known intolerance or allergy to paracetamol (acetaminophen)
  16. Active substance abuse
  17. Previous entry into this study or simultaneous participation in another clinical drug trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504530

Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Peter Brinsden, M.D. Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR
  More Information

Publications:
Responsible Party: Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00504530     History of Changes
Other Study ID Numbers: 23079
Study First Received: July 18, 2007
Last Updated: February 17, 2014
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014