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.

Merck KGaA, Darmstadt, Germany0 sites50 target enrollmentSeptember 2001

ConditionsInfertility Implantation Failure

DrugsEmfilermin, recombinant human leukemia inhibitory factor (r-hLIF)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Infertility Implantation Failure
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 50
Primary Endpoint: Improvement of embryo implantation and Safety
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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 following ART. Based on LIF expression patterns and experimental data from animal research a role of LIF in embryo implantation is anticipated.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

April 2002

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Eligibility Criteria

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.

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