A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

Sponsor

Isifer AB (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03386552

Collaborator

Ferring Pharmaceuticals (Industry), Vinnova (Other)

120

Enrollment

Location

Arms

21.3

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Unexplained Infertility	Drug: Isifera+ Drug: Buffer	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 20, 2017

Anticipated Primary Completion Date :

May 31, 2018

Anticipated Study Completion Date :

Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isifera+ Subjects are pertubated with Isifer+ solution containing lidocaine 0.5 mg/ml	Drug: Isifera+ Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer
Placebo Comparator: Buffer Subjects are pertubated with a buffer solution without lidocaine	Drug: Buffer Pertubation solution of Ringer-Acetate buffer

Arm

Intervention/Treatment

Experimental: Isifera+

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

Drug: Isifera+

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

Placebo Comparator: Buffer

Subjects are pertubated with a buffer solution without lidocaine

Drug: Buffer

Pertubation solution of Ringer-Acetate buffer

Outcome Measures

Primary Outcome Measures

Pregnancy rate [day 14-17 after IUI]
serum-HCG

Secondary Outcome Measures

Baby take home rate [At delivery / Miscarriage]
Delivery of baby

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	InviMed-T sp. z o.o	Warszawa		Poland	02-532

Sponsors and Collaborators

Isifer AB
Ferring Pharmaceuticals
Vinnova

Investigators

Study Chair: Jack Spira, Md PhD, Isifer AB

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Isifer AB

ClinicalTrials.gov Identifier:

NCT03386552

Other Study ID Numbers:

ISI-2015-1

First Posted:

Dec 29, 2017

Last Update Posted:

Dec 29, 2017

Last Verified:

Dec 1, 2017

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.:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Dec 29, 2017