A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-09-30

Brief Summary

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The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pertubation with Lidocain Solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No