NCT02315040

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_3

Geographic Reach
4 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 7, 2017

Status Verified

January 1, 2017

Enrollment Period

5.3 years

First QC Date

October 19, 2014

Last Update Submit

June 6, 2017

Conditions

Insemination

Keywords

Intrauterine insemination (IUI)Insemination methodSlow release insemination (SRI)EVIEPregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    ß-HCG examination in urine or serum

    average time frame: 2 weeks after insemination

Study Arms (2)

IUI

ACTIVE COMPARATOR

standard intrauterine insemination method

Other: Standard Intrauterine Insemination

EVIE

EXPERIMENTAL

Slow release insemination method (SRI)

Device: EVIE

Interventions

EVIEDEVICE

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

Also known as: Slow Release Insemination (SRI)
EVIE
Standard Intrauterine InseminationOTHER

standard intrauterine insemination procedure

Also known as: IUI
IUI

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Das Kinderwunsch Institut Schenk GmbH

Dobl, 8143, Austria

COMPLETED

Dept. Obstetrics and Gynaecology, Medical University of Vienna

Vienna, 1090, Austria

ACTIVE NOT RECRUITING

Kinderwunschzentrum der Goldenes Kreuz Privatklinik

Vienna, 1090, Austria

ACTIVE NOT RECRUITING

CRES Hopital Natecia

Lyon, 69008, France

COMPLETED

Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen

Aachen, Westfalen, 52074, Germany

ACTIVE NOT RECRUITING

Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe

Frankfurt am Main, 60590, Germany

ACTIVE NOT RECRUITING

Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216

Karlsruhe, 76135, Germany

COMPLETED

LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

Munich, 80337, Germany

ACTIVE NOT RECRUITING

Kinderwunsch Centrum München Pasing

Munich, 81241, Germany

COMPLETED

Kinderwunschzentrum München Bogenhausen

Munich, 81675, Germany

ACTIVE NOT RECRUITING

Fertility Fusion/Withington Hospital

Withington, Lancashire, WN6 9EP, United Kingdom

RECRUITING

Centre for Reproductive and Genetic Health - Eastman Dental Hospital

London, UK, WC1X8LD, United Kingdom

RECRUITING

Related 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. doi: 10.1093/oxfordjournals.humrep.a137622.

    PMID: 1577936BACKGROUND

Study Officials

  • Maximilian B Franz, MD

    Medical University of Vienna

    STUDY CHAIR

  • Christian Egarter, MD, Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Julian Marschalek, MD

    Medical University of Vienna

    STUDY CHAIR

Central Study Contacts

Julian Marschalek, MD

CONTACT

+4314040028160julian.marschalek@meduniwien.ac.at

Maximilian B Franz, MD

CONTACT

+49 177 2707670mf@gyn-bogenhausen.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 19, 2014

First Posted

December 11, 2014

Study Start

March 1, 2012

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

June 7, 2017

Record last verified: 2017-01

Locations

FR(1)DE(6)GB(2)AU(3)