A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

• Status: Unknown status
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: Female

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 pertubation, i.e. flushing the uterus and fallopian tubes before insemination with a specially developed solution with the aim to increase fertility. The clinical trial is a phase II double blind, randomized, controlled and multi-center trial .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isifer AB
• Collaborators: Ferring Pharmaceuticals; Vinnova

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, 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 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.