Status:
UNKNOWN
A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility
Lead Sponsor:
Isifer AB
Collaborating Sponsors:
Ferring Pharmaceuticals
Vinnova
Conditions:
Unexplained Infertility
Eligibility:
FEMALE
20-38 years
Phase:
PHASE2
Brief Summary
The present investigation is evaluating a method for improving pregnancy outcome of couples with unexplained infertility. The method utilizes an adjuvant pre-treatment prior to insemination, that is p...
Detailed Description
Couples interested in participating in the clinical study must have undergone a complete investigation for their infertility and have at least one year of unsuccessful attempts to achieve pregnancy. F...
Eligibility Criteria
Inclusion
- 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, rubella and hormonal screen within normal range. Furthermore patent fallopian tubes should be confirmed by ultrasound hysterosalpingography and males should present a normal semen analysis
Exclusion
- 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.
Key Trial Info
Start Date :
June 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03386552
Start Date
June 20 2017
End Date
March 31 2019
Last Update
December 29 2017
Active Locations (1)
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1
InviMed-T sp. z o.o
Warsaw, Poland, 02-532