A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Phase 2
Completed
- Conditions
- Infertility
- Registration Number
- NCT00449449
- Lead Sponsor
- Isifer AB
- Brief Summary
The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.
- Detailed Description
In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 330
Inclusion Criteria
- Female,
- 20-40 years of age,
- If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),
- Normal menstruation cycle,
- Male partner 20-70 years of age,
- Male partner,
- Normal sperm sample within 5 years (>20x106/mL, total sperm count >30x106, normal morphology 5%),
- Duration of infertility more than one year,
- Signed informed consent
Exclusion Criteria
- Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,
- Clinical signs of PID,
- Known hypersensitivity to local anesthetics,
- Non-patent fallopian tubes,
- Pathological uterine cavity,
- Pathological PCT, myoma > 2 cm diameter,
- Any disease or laboratory finding considered of importance by the investigator not to include the patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method clinical pregnancy
- Secondary Outcome Measures
Name Time Method Pregnancy rate measured by Serum-HCG day 17 after IUI
Trial Locations
- Locations (1)
1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge
🇸🇪Stockholm, Sweden