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A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status

Unknown status

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

Isifera+

Buffer

About this trial

This is an interventional treatment trial for Unexplained Infertility

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Couples must fulfil all laboratory tests for inclusion, negative HIV-1, HCV, HBV, CMV virology, chlamydia and syphilis. For female also negative toxoplasmosis, rubella and hormonal screen within normal range. Furthermore patent fallopian tubes should be confirmed by ultrasound hysterosalpingography and males should present a normal semen analysis

Exclusion Criteria:

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.

Sites / Locations

InviMed-T sp. z o.oRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Isifera+

Buffer

Arm Description

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

Subjects are pertubated with a buffer solution without lidocaine

Outcomes

Primary Outcome Measures

Pregnancy rate

serum-HCG

Secondary Outcome Measures

Baby take home rate

Delivery of baby

Full Information

NCT ID

NCT03386552

First Posted

December 21, 2017

Last Updated

December 28, 2017

Sponsor

Isifer AB

Collaborators

Ferring Pharmaceuticals, Vinnova

1. Study Identification

Unique Protocol Identification Number

NCT03386552

Brief Title

A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

Official Title

A Randomized, Double Blind, Controlled, Parallel Groups, Multi-center Phase II Clinical Study of Lidocaine Pertubation as a Treatment for Couples With Unexplained Infertility

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

May 31, 2018 (Anticipated)

Study Completion Date

March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Isifer AB

Collaborators

Ferring Pharmaceuticals, Vinnova

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 .

Detailed Description

Couples interested in participating in the clinical study must have undergone a complete investigation for their infertility and have at least one year of unsuccessful attempts to achieve pregnancy. Following inclusion in the study, patients will be monitored with vaginal ultrasound to ensure a leading follicle of at least 18 mm.The subjects with one or two follicles ≥18 mm will be given Ovitrelle® (Merck), dose 250 ug (6500 IU) of Human Chorionic Gonadotropin (HCG), subcutaneously for ovulation induction. 12-24 h after the HCG injection, patients will be randomized and pertubated with either test or control solution. 12 -24 hours after the pertubation insemination (IUI) will be given to all patients. A blood sample is taken 14-17 days after IUI, for analysis of serum HCG level and possible pregnancy. In case of positive answer a second confirmatory sample will be obtained 48-72 hours later. In case of confirmed elevated HCG, the clinical pregnancy (CP) will be assessed with vaginal ultrasound examination 6-7 week after IUI. Baby take home rate data will be collected for couples with clinical pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unexplained Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Isifera+

Arm Type

Experimental

Arm Description

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

Arm Title

Buffer

Arm Type

Placebo Comparator

Arm Description

Subjects are pertubated with a buffer solution without lidocaine

Intervention Type

Drug

Intervention Name(s)

Isifera+

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Buffer

Intervention Description

Pertubation solution of Ringer-Acetate buffer

Primary Outcome Measure Information:

Title

Pregnancy rate

Description

serum-HCG

Time Frame

day 14-17 after IUI

Secondary Outcome Measure Information:

Title

Baby take home rate

Description

Delivery of baby

Time Frame

At delivery / Miscarriage

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Couples must fulfil all laboratory tests for inclusion, negative HIV-1, HCV, HBV, CMV virology, chlamydia and syphilis. For female also negative toxoplasmosis, rubella and hormonal screen within normal range. Furthermore patent fallopian tubes should be confirmed by ultrasound hysterosalpingography and males should present a normal semen analysis Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tomasz Rokicki, MD, PhD

Phone

+48 500 900 888

t-rokicki@invimed.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack Spira, Md PhD

Organizational Affiliation

Isifer AB

Official's Role

Study Chair

Facility Information:

Facility Name

InviMed-T sp. z o.o

City

Warszawa

ZIP/Postal Code

02-532

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomasz Rokicki, MD, PhD

Phone

+48 500 900 888

t-rokicki@invimed.pl

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

result

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/18281242

Description

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

Learn more about this trial

A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

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