A study of using a solution flushed through the womb (pertubation) to increase fertility rate for couples with unexplained infertility.
- Conditions
- nexplained infertilityTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2016-001950-16-PL
- Lead Sponsor
- Isifer AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>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 Outcome Measures
Name Time Method Secondary end point(s): Baby take home rate;Timepoint(s) of evaluation of this end point: At delivery /term