A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

NCT03386552 | Unknown Phase 2

• 1 other identifier: ISI-2015-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  serum-HCG

  day 14-17 after IUI

Secondary Outcomes (1)

• Baby take home rate

  At delivery / Miscarriage

Study Arms (2)

Isifera+

EXPERIMENTAL

Subjects are pertubated with Isifer+ solution containing lidocaine 0.5 mg/ml

Drug: Isifera+

Buffer

PLACEBO COMPARATOR

Subjects are pertubated with a buffer solution without lidocaine

Drug: Buffer

Interventions

Isifera+ DRUG

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

Isifera+

Buffer DRUG

Pertubation solution of Ringer-Acetate buffer

Buffer

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females with, unexplained infertility, 20-38 years of age. Normal menstrual cycle length of 26-35 days, male partner 20-70 years of age, Duration of infertility should have lasted more than one year and subject should have signed informed consent.

You may not qualify if:

• Continuous treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection, clinical signs of PID, known hypersensitivity to local anaesthetics, non-patent fallopian tubes, abnormal uterine cavity, submucous myoma \> 2 cm in diameter, any disease or laboratory finding considered of importance by the investigator not to include the patient, laparoscopically confirmed endometriosis of greater severity than mild, endometriosis of any severity with adhesions. More than 2 previous inseminations or previous unsuccessful IVF treatment.

Sponsors & Collaborators

• Isifer AB: lead
• Ferring Pharmaceuticals: collaborator
• Vinnova: collaborator

Study Sites (1)

InviMed-T sp. z o.o

Warsaw, 02-532, Poland

RECRUITING

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: 18281242 RESULT

Related Links

• A new rapid and effective method for treatment of unexplained infertility.

MeSH Terms

Interventions

Buffers

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Jack Spira, Md PhD

  Isifer AB

  STUDY CHAIR

Central Study Contacts

Tomasz Rokicki, MD, PhD

CONTACT

+48 500 900 888; t-rokicki@invimed.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: June 20, 2017
• Primary Completion: May 31, 2018
• Study Completion: March 31, 2019
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

PL (1)