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

Insemination Clinical Trial

— EVIE  

Official title:

Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02315040
• Other study ID #: V1.2
• Status: Recruiting
• Phase: Phase 3
• First received: October 19, 2014
• Last updated: June 6, 2017
• Start date: March 2012
• Est. completion date: August 2017

Study information

• Verified date: January 2017
• Source: Medical University of Vienna
• Contact: Julian Marschalek, MD
• Phone: +4314040028160
• Email: julian.marschalek[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Insemination

Intervention

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:
• Standard Intrauterine Insemination
standard intrauterine insemination procedure

Locations

Country	Name	City	State
Austria	Das Kinderwunsch Institut Schenk GmbH	Dobl
Austria	Dept. Obstetrics and Gynaecology, Medical University of Vienna	Vienna
Austria	Kinderwunschzentrum der Goldenes Kreuz Privatklinik	Vienna
France	CRES Hopital Natecia	Lyon
Germany	Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen	Aachen	Westfalen
Germany	Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe	Frankfurt am Main
Germany	Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216	Karlsruhe
Germany	Kinderwunsch Centrum München Pasing	Munich
Germany	Kinderwunschzentrum München Bogenhausen	Munich
Germany	LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe	Munich
United Kingdom	Centre for Reproductive and Genetic Health - Eastman Dental Hospital	London	UK
United Kingdom	Fertility Fusion/Withington Hospital	Withington	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Reproductive Sciences Ltd.

Countries where clinical trial is conducted

Austria,  France,  Germany,  United Kingdom, 

References & Publications (1)

Muharib NS, Abdel Gadir A, Shaw RW. Slow release intrauterine insemination versus the bolus technique in the treatment of women with cervical mucus hostility. Hum Reprod. 1992 Feb;7(2):227-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	ß-HCG examination in urine or serum	average time frame: 2 weeks after insemination