r-hLIF for Improving Embryo Implantation in IVF

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00504530
• Date of registration: 18/07/2007
• Primary sponsor: Merck KGaA
• Public title: r-hLIF for Improving Embryo Implantation in IVF
• Scientific 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.
• Date of first enrolment: September 2001
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00504530
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: Peter Brinsden, M.D.
• Affiliation: Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 36 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility, Implantation Failure.

Intervention(s)

Drug: Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)

Primary Outcome(s)

Improvement of embryo implantation and Safety [Time Frame: Various]

Secondary Outcome(s)

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

Secondary ID(s)

23079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors