A Multicentre, Randomised, Double-blind, Placebo-controlled Proof of Concept Study to Compare the Efficacy and Safety of r-hLIF (Emfilermin) for Improving Embryo Implantation Following in Vitro Fertilization (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure

Merck KGaA, Darmstadt, Germany0 sites150 target enrollmentApril 2003

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: 150
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

The primary objective of the study was to provide further clinical and statistical evidence of the efficacy of r-hLIF, in comparison with placebo, administered during the luteal phase after IVF and ET for improving embryo implantation in infertile women with a history of at least 2 implantation failures following transfer of fresh embryos. The secondary objective of the study was to assess the safety profile of r-hLIF in the proposed indication.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

April 2004

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 21-37 years inclusive at time of consent.
•Infertile woman justifying IVF-ET treatment and wishing to conceive.
•The presence of both ovaries.
•Current body mass index (BMI) of ≥ 20 \& ≤ 30 kg/m2
•Early follicular phase (cycle day 2-5) serum FSH levels ≤ 10 IU/L. If two determinations are available, at least one should be \< 10 IU/L.
•History of:
•≥ 2 ART cycles with adequate stimulation that led to the transfer of at least two or more fresh Grade A or B embryos, but did not result in implantation or
•≥ 3ART cycles with adequate stimulation that led to the transfer of at least one fresh Grade A or B embryo from a cohort with one additional Grade A or B embryo, but did not result in implantation
•Normal male partner's semen analysis according to standard WHO criteria. Male partner's semen analysis must be suitable for IVF (ICSI not allowed). Donor sperm is allowed.
•Normal cervical cytology within 3 years prior to starting GnRH-agonist therapy.

Exclusion Criteria

•Known to be positive for Human Immunodeficiency Virus, Hepatitis B or C Virus.
•History of any liver disease.
•Any one of the following parameters above the upper limit of normal at the prestudy visit: AST, ALT, Alkaline phosphatases, gamma GT, alpha GST, bilirubin.
•Any clinically significant systemic disease.
•Any significant allergic disease.
•Presence of an uncontrolled clinically significant medical condition including infection) as determined by the investigator.
•History of ART biochemical pregnancy.
•Any cause of infertility that would justify ICSI treatment
•Presence of another known cause of previous ART failure other than recurrent implantation failure.
•Uterine cavity with abnormalities which, in the investigator's opinion, could impair embryo implantation or pregnancy outcome, as assessed by US examination performed within 6 months prior to starting GnRH-agonist therapy.