NCT00449449

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
Last Updated

March 20, 2007

Status Verified

March 1, 2007

First QC Date

March 17, 2007

Last Update Submit

March 19, 2007

Conditions

Infertility

Keywords

Pertubation, tubal flushing, intrauterine insemination.

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy

Secondary Outcomes (1)

  • Pregnancy rate measured by Serum-HCG day 17 after IUI

Interventions

Pertubation with Lidocain SolutionDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, Stockholm County, 141 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 18281242DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Greta Edelstam, Md. PhD

    Department of Obstetrics and Gynecology, Karolinska University Hospital at Huddinge, S-141 86 Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2007

First Posted

March 20, 2007

Study Start

September 1, 2003

Study Completion

September 1, 2006

Last Updated

March 20, 2007

Record last verified: 2007-03

Locations

SE(1)