Prospective, double-blind, randomized, placebo-controlled, parallel group, multi-centre phase III study to evaluate the efficacy and safety of a human leukocytic ultrafiltrate (Leukonorm Cytochemia®) applied as supportive immunotherapy within IVF/ICSI-treatment in female patients with repetitive implantation failures during previous IVF or ICSI-cycles - CYCLE

• Conditions: female patients with repetitive implantation failures during previous IVF/ICSI-cycles

• Registration Number: EUCTR2006-000014-20-DE
• Lead Sponsor: CYTOCHEMIA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 208

Inclusion Criteria

·woman aged 18 to 39 years;
·patients with a history of not less than 2 but not more than 3 previous failed IVF/ICSI-cycles (i.e. no constantly high serum-hCG and/or no clinical evidence for at least one embryo sac, determined by transvaginal sonography), with at least 4 morphologically good-looking embryos of the categories A and B according to Steer et al.
·stimulation according to the long GnRH-agonist protocol or according to the GnRH-antagonist protocol (for details refer to section 9.5.1.1)
·written informed consent obtained.
A complete list of all inclusion criteria is given in the protocol section 9.3.2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·patients with known or suspected uterine malformation
·patients with known or suspected endometriosis class III and IV, according to rAFS-criteria
·known or suspected numerical and/or structural chromosomal anomalies in one or both partners

·usage of cryopreserved unfertilized oocytes, oocytes at the pronuclear stage, or embryos
·previous low response (< 5 oocytes retrieved) in a gonadotropin stimulation GnRH agonist or anatagonist protocol for IVF or ICSI
·clinical significant findings of a severe autoimmune disease, respectively clinical manifested severe autoimmune disease (e.g. rheumatoid arthritis, multiple sclerosis) and/or currently treated autoimmune disease
·any kind of organ transplantation
·patients receiving immunosuppressive therapy, including systemic corticosteroids, or cytotoxic agents
A complete list of all exclusion criteria is given in the protocol section 9.3.3.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show that the efficacy of LeukoNorm CytoChemia® applied as supportive immunotherapy within IVF/ICSI-treatment is superior to placebo with respect to an increased pregnancy rate;Secondary Objective: To investigate the safety and tolerability of LeukoNorm CytoChemia® injection within a therapy scheme of 10 intra-muscular injections;Primary end point(s): The primary efficacy variable will be the rate of successful pregnancies, measured by clinical methods (transvaginal sonography). Thereby a positive heart activity within at least one intrauterine embryonic sac will be regarded as successful pregnancy.