Status:
COMPLETED
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Lead Sponsor:
Isifer AB
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Infertility
Eligibility:
FEMALE
20-40 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00449449
Start Date
September 1 2003
End Date
September 1 2006
Last Update
March 20 2007
Active Locations (1)
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1
1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge
Stockholm, Stockholm County, Sweden, 141 86