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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02315040
Date of registration:	19/10/2014
Prospective Registration:	No
Primary sponsor:	Medical University of Vienna
Public title:	EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study EVIE
Scientific title:	Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
Date of first enrolment:	March 2012
Target sample size:	250
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02315040
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Austria	France	Germany	United Kingdom

Contacts

Name:	Julian Marschalek, MD
Address:
Telephone:	+4314040028160
Email:	julian.marschalek@meduniwien.ac.at
Affiliation:

Name:	Christian Egarter, MD, Prof.
Address:
Telephone:
Email:
Affiliation:	Medical University of Vienna

Name:	Julian Marschalek, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of Vienna

Name:	Maximilian B Franz, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of Vienna

Key inclusion & exclusion 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

Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Insemination

Intervention(s)

Device: EVIE

Other: Standard Intrauterine Insemination

Primary Outcome(s)

Pregnancy rate [Time Frame: average time frame: 2 weeks after insemination]

Secondary Outcome(s)

Secondary ID(s)

V1.2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Reproductive Sciences Ltd.

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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