InseminationPhase 3EVIENCT02315040
EVIE-Study: Slow Release Insemination Versus Standard Intrauterine Insemination Study
A Phase 3 study testing EVIE and Standard Intrauterine Insemination in people with Insemination, run by Medical University of Vienna at 12 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insemination
- What is being tested?
- EVIE and Standard Intrauterine Insemination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Mar 2012to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany6 sites
- Active, not recruiting
Dept. Obstetrics and Gynaekology, Medical Faculty of Aachen
Aachen, Westfalen, 52074
- Active, not recruiting
Klinikum der Johann Wolfgang-Goethe-Universität Klinik für Frauenheilkunde und Geburtshilfe
Frankfurt am Main, 60590
- Completed
Frauenärztliche Gemeinschaftspraxis Dr. Maarten R. van Santen; KriegsstraBe 216
Karlsruhe, 76135
- Active, not recruiting
LMU, Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Munich, 80337
- Completed
Kinderwunsch Centrum München Pasing
Munich, 81241
- Active, not recruiting
Kinderwunschzentrum München Bogenhausen
Munich, 81675
Austria3 sites
- Completed
Das Kinderwunsch Institut Schenk GmbH
Dobl, 8143
- Active, not recruiting
Dept. Obstetrics and Gynaecology, Medical University of Vienna
Vienna, 1090
- Active, not recruiting
Kinderwunschzentrum der Goldenes Kreuz Privatklinik
Vienna, 1090
United Kingdom2 sites, 2 recruiting
- Recruiting
Centre for Reproductive and Genetic Health - Eastman Dental Hospital
London, UK, WC1X8LD
Wael Saab, MD, +44 207 837 2905, wael.saab@crgh.co.uk
- Recruiting
Fertility Fusion/Withington Hospital
Withington, Lancashire, WN6 9EP
C Philip Harris, MD, +44 (0) 1257 256251, info@fertilityfusion.co.uk
About this study
Official title: Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
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.
Read more
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.
- Conditions
- Insemination
- Being tested
- EVIE, Standard Intrauterine Insemination
- Keywords
- Intrauterine insemination (IUI), Insemination method, Slow release insemination (SRI), EVIE, Pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVIEDevice
Also called Slow Release Insemination (SRI)
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
Standard Intrauterine InseminationOther
Also called IUI
standard intrauterine insemination procedure
| Study group | Role | What they receive |
|---|---|---|
| IUI | Active comparator | standard intrauterine insemination method Receives: Other: Standard Intrauterine Insemination |
| EVIE | Experimental | Slow release insemination method (SRI) Receives: Device: EVIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
ß-HCG examination in urine or serum
Measured: average time frame: 2 weeks after insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startMar 2012
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InseminationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Reproductive Sciences Ltd.
- Responsible party
- Principal investigator, Maximilian Franz, M.D., Medical University of Vienna
- Investigators
- Maximilian B Franz, MD, Study chair, Medical University of ViennaChristian Egarter, MD, Prof., Principal investigator, Medical University of ViennaJulian Marschalek, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315040
- Sponsor's protocol ID
- V1.2
- Acronym
- EVIE
- Status last verified
- Jan 2017
- First submitted
- 19 Oct 2014
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 1577936
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of Intrauterine Slow Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination (IUI)
- ClinicalTrials.gov ID
- NCT02315040
- Acronym / sponsor ID
- EVIE / V1.2
- Conditions
- Insemination
- Keywords
- Intrauterine insemination (IUI), Insemination method, Slow release insemination (SRI), EVIE, Pregnancy rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Reproductive Sciences Ltd.
- Study start
- Mar 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUI | Active comparator | Other: Standard Intrauterine Inseminationstandard intrauterine insemination method |
| EVIE | Experimental | Device: EVIESlow release insemination method (SRI) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVIEAlso: Slow Release Insemination (SRI)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 | Device | EVIE |
| Standard Intrauterine InseminationAlso: IUIstandard intrauterine insemination procedure | Other | IUI |
Primary outcome
Pregnancy rate
Time frame: average time frame: 2 weeks after insemination
ß-HCG examination in urine or serum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Background: PubMed 1577936Muharib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian B Franz, MD study chair
Medical University of Vienna
Christian Egarter, MD, Prof. principal investigator
Medical University of Vienna
Julian Marschalek, MD study chair
Medical University of Vienna
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EVIE and Standard Intrauterine Insemination in people with Insemination, run by Medical University of Vienna at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Austria, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Marschalek, MD (+4314040028160, julian.marschalek@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: average time frame: 2 weeks after insemination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.