EVIE-Study: Slow Release Insemination Versus Standard Int... | NCT02315040

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jul 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Oct 19, 2014

First Submission Date that Met QC Criteria

Dec 9, 2014

First Posted Date

Dec 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2017

Last Update Posted Date

Jun 7, 2017Actual

Name	Class
Reproductive Sciences Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IUI	Active Comparator	standard intrauterine insemination method	Other: Standard Intrauterine Insemination
EVIE	Experimental	Slow release insemination method (SRI)	Device: EVIE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVIE	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julian Marschalek, MD	Contact	+4314040028160		julian.marschalek@meduniwien.ac.at
Maximilian B Franz, MD	Contact	+49 177 2707670		mf@gyn-bogenhausen.de

Overall Officials

Name	Affiliation	Role
Maximilian B Franz, MD	Medical University of Vienna	Study Chair
Christian Egarter, MD, Prof.	Medical University of Vienna	Principal Investigator
Julian Marschalek, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Das Kinderwunsch Institut Schenk GmbH	Completed	Dobl		8143	Austria
Dept. Obstetrics and Gynaecology, Medical University of Vienna

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1577936	Background	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. doi: 10.1093/oxfordjournals.humrep.a137622.