Unexplained infertility
Conditions
Interventions
Product Name: Isifera plus
Product Code: Isifera plus
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Lidocaine
CAS Number: 6108-05-0
Current Sponsor code: Isifera+
Other des
Sponsors
Isifer AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Females with, unexplained infertility, 20-38 years of age. Normal menstrual cycle length of 26-35 days, male partner 20-70 years of age, Duration of infertility should have lasted more than one year and subject should have signed informed consent. Couples must fulfil all laboratory tests for inclusion, negative HIV-1, HCV HBV, CMV virology, chlamydia and syphilis. For female also negative toxoplasmosis and rubella test. Furthermore patent fallopian tubes should be confirmed by hysterosalpingography and males should present a normal semen analysis. 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Continuous treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection, clinical signs of PID, known hypersensitivity to local anaesthetics, non-patent fallopian tubes, abnormal uterine cavity, submucous myoma > 2 cm in diameter, any disease or laboratory finding considered of importance by the investigator not to include the patient, laparoscopically confirmed endometriosis of greater severity than mild, endometriosis of any severity with adhesions. More than 2 previous inseminations or previous unsuccessful IVF treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy on fertility rate of preovulatory pertubation with “Isifera +”;Secondary Objective: To study the safety and tolerability of preovulatory pertubation with “Isifera plus” solution containing 0.5 mg/ml lidocain. To study the baby take home rate;Primary end point(s): Pregnancy rate measured by serum-HCG day 14-17 after IUI and confirmed 48-72 hours later, or in case of no serum-HCG taken, US verified pregnancy at week 6-7 post IUI.;Timepoint(s) of evaluation of this end point: Pregnancy rate measured by serum-HCG day 14-17 after IUI and confirmed 48-72 hours later, or in case of no serum-HCG taken, US verified pregnancy at week 6-7 post IUI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Baby take home rate;Timepoint(s) of evaluation of this end point: At delivery /term | — |
Countries
Poland
Contacts
Public ContactJack Spira
InSpira Medical AB
Outcome results
None listed