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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Pertubation with Lidocain Solution
Sponsored by
Isifer AB
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Pertubation, tubal flushing, intrauterine insemination.

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • 1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge

Outcomes

Primary Outcome Measures

clinical pregnancy

Secondary Outcome Measures

Pregnancy rate measured by Serum-HCG day 17 after IUI

Full Information

First Posted
March 17, 2007
Last Updated
March 19, 2007
Sponsor
Isifer AB
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT00449449
Brief Title
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Official Title
A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Isifer AB
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Pertubation, tubal flushing, intrauterine insemination.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pertubation with Lidocain Solution
Primary Outcome Measure Information:
Title
clinical pregnancy
Secondary Outcome Measure Information:
Title
Pregnancy rate measured by Serum-HCG day 17 after IUI

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greta Edelstam, Md. PhD
Organizational Affiliation
Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge, S-141 86 Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
1. Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18281242
Citation
Edelstam G, Sjosten A, Bjuresten K, Ek I, Wanggren K, Spira J. A new rapid and effective method for treatment of unexplained infertility. Hum Reprod. 2008 Apr;23(4):852-6. doi: 10.1093/humrep/den003. Epub 2008 Feb 15.
Results Reference
derived

Learn more about this trial

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

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