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EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study (EVIE)

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ClinicalTrials.gov Identifier: NCT02315040
Recruitment Status : Unknown
Verified January 2017 by Maximilian Franz, M.D., Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Reproductive Sciences Ltd.
Information provided by (Responsible Party):
Maximilian Franz, M.D., Medical University of Vienna

Brief Summary:

Overall Study Design and Plan Description

  • The study will be conducted on women with fertility difficulties who are designated for intrauterine insemination treatment (IUI). The research sample size is 137 treatment cycles per group (total of 274 treatment cycles). The women will be randomly divided into two groups. Some will undergo the standard bolus IUI treatment and others will be treated with the EVIE Slow Release Insemination method (SRI). Women who fail to conceive in the first treatment will next receive the alternative treatment. This means that a woman treated with the IUI method who does not become pregnant will then be treated with SRI, and vice versa (crossover method). The study will include women treated with Clomiphene Citrate or with other Gonadotropin-based treatment. Every couple treated will undergo at least 2 insemination cycles (unless pregnancy has already been achieved).
  • Before beginning the hormone treatment, each couple will have the trial procedure explained to them. This explanation will include all the detailed information and instruction about the IUI and the Slow Release Insemination methods. A Patient Information Sheet will be available to them.
  • Preparation of the spermatozoa for intra uterine insemination will be identical to the method performed currently before IUI.

Approximately two weeks after the insemination treatment, a blood sample will be taken from the woman to check for Beta hCG levels to indicate pregnancy.

Hypothesis:

SRI leads to higher pregnancy rates compared to standard IUI

Primary endpoint:

• Pregnancy rate Effect of controlled Intra-uterine slow release insemination on the pregnancy rate of women designated for intra uterine insemination in comparison to the accepted IUI method.


Condition or disease Intervention/treatment Phase
Insemination Device: EVIE Other: Standard Intrauterine Insemination Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
Study Start Date : March 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: IUI
standard intrauterine insemination method
Other: Standard Intrauterine Insemination
standard intrauterine insemination procedure
Other Name: IUI

Experimental: EVIE
Slow release insemination method (SRI)
Device: EVIE
EVIE is a small, mechanical, single use pump that mimics natural fertilization by introducing sperm into the uterus over a period of 4 hours, rather than all at once as in conventional IUI
Other Name: Slow Release Insemination (SRI)




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: average time frame: 2 weeks after insemination ]
    ß-HCG examination in urine or serum



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women with primary or secondary infertility after 6 months of unprotected intercourse who are candidates for IUI
  2. Age of the woman - 20 to 40 years old
  3. Normal uterus x-ray (HSG) or Chromotubation to determine tubal patency
  4. Women with infertility on a background of non-ovulation
  5. Infertility on a background of a male problem (over 10 million/ml motile sperm cells per sample)
  6. Infertility on a background of unexplained cause
  7. Same sex patient / single patient
  8. Signed informed consent

Exclusion Criteria:

  1. Woman under the age of 20 or over the age of 40 years
  2. Female infertility on mechanical background affecting the uterus or Fallopian tubes
  3. Infertility on male background of medium to very low level of spermatozoa - less than 10 million/ml motile sperm cells per sample
  4. Men and women who are opposed to the random spermatozoa insemination method
  5. Participants who are not willing to sign the Consent Form
  6. BMI >30

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315040


Contacts
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Contact: Julian Marschalek, MD +4314040028160 julian.marschalek@meduniwien.ac.at
Contact: Maximilian B Franz, MD +49 177 2707670 mf@gyn-bogenhausen.de

Locations
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Austria
Das Kinderwunsch Institut Schenk GmbH Completed
Dobl, Austria, 8143
Dept. Obstetrics and Gynaecology, Medical University of Vienna Active, not recruiting
Vienna, Austria, 1090
Kinderwunschzentrum der Goldenes Kreuz Privatklinik Active, not recruiting
Vienna, Austria, 1090
France
CRES Hopital Natecia Completed
Lyon, France, 69008
Germany
Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen Active, not recruiting
Aachen, Westfalen, Germany, 52074
Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe Active, not recruiting
Frankfurt am Main, Germany, 60590
Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216 Completed
Karlsruhe, Germany, 76135
LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Active, not recruiting
Munich, Germany, 80337
Kinderwunsch Centrum München Pasing Completed
Munich, Germany, 81241
Kinderwunschzentrum München Bogenhausen Active, not recruiting
Munich, Germany, 81675
United Kingdom
Fertility Fusion/Withington Hospital Recruiting
Withington, Lancashire, United Kingdom, WN6 9EP
Contact: C Philip Harris, MD    +44 (0) 1257 256251    info@fertilityfusion.co.uk   
Centre for Reproductive and Genetic Health - Eastman Dental Hospital Recruiting
London, UK, United Kingdom, WC1X8LD
Contact: Wael Saab, MD    +44 207 837 2905    wael.saab@crgh.co.uk   
Sponsors and Collaborators
Medical University of Vienna
Reproductive Sciences Ltd.
Investigators
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Study Chair: Maximilian B Franz, MD Medical University of Vienna
Principal Investigator: Christian Egarter, MD, Prof. Medical University of Vienna
Study Chair: Julian Marschalek, MD Medical University of Vienna

Publications:
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Responsible Party: Maximilian Franz, M.D., MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02315040     History of Changes
Other Study ID Numbers: V1.2
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: January 2017

Keywords provided by Maximilian Franz, M.D., Medical University of Vienna:
Intrauterine insemination (IUI)
Insemination method
Slow release insemination (SRI)
EVIE
Pregnancy rate