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A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

NCT03386552 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-29

No results posted yet for this study

Summary

The present investigation is evaluating a method for improving pregnancy outcome of couples with unexplained infertility. The method utilizes an adjuvant pre-treatment prior to insemination, that is pertubation, i.e. flushing the uterus and fallopian tubes before insemination with a specially developed solution with the aim to increase fertility. The clinical trial is a phase II double blind, randomized, controlled and multi-center trial .

Conditions

  • Unexplained Infertility

Interventions

DRUG

Isifera+

Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer

DRUG

Buffer

Pertubation solution of Ringer-Acetate buffer

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Vinnova

    collaborator OTHER_GOV

  • Isifer AB

    lead INDUSTRY

Principal Investigators

  • Jack Spira, Md PhD · Isifer AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2018-05-31
Completion
2019-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386552 on ClinicalTrials.gov