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A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility

NCT ID: NCT03386552

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Unexplained Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Isifera+

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

Group Type EXPERIMENTAL

Isifera+

Intervention Type DRUG

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

Buffer

Subjects are pertubated with a buffer solution without lidocaine

Group Type PLACEBO_COMPARATOR

Buffer

Intervention Type DRUG

Pertubation solution of Ringer-Acetate buffer

Interventions

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Isifera+

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

Intervention Type DRUG

Buffer

Pertubation solution of Ringer-Acetate buffer

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Vinnova

OTHER_GOV

Sponsor Role collaborator

Isifer AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jack Spira, Md PhD

Role: STUDY_CHAIR

Isifer AB

Locations

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InviMed-T sp. z o.o

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Tomasz Rokicki, MD, PhD

Role: CONTACT

Phone: +48 500 900 888

Email: [email protected]

Facility Contacts

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Tomasz Rokicki, MD, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 18281242 (View on PubMed)

Related Links

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

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

Other Identifiers

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ISI-2015-1

Identifier Type: -

Identifier Source: org_study_id