female patients with repetitive implantation failures during previous IVF/ICSI-cycles
Conditions
Interventions
Trade Name: LEUKONORM CYTOCHEMIA
Product Name: LeukoNorm CytoChemia®
Product Code: N.A.
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder a
Sponsors
CYTOCHEMIA AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed