Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02315040
Status:
UNKNOWN
Last Update Posted:
2017-06-07
First Post:
2014-10-19
Brief Title:
EVIE-Study Slow Release Insemination Versus Standard Intrauterine Insemination Study
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Testing the Effect of Intrauterine Slow Release Insemination SRI on the Pregnancy Rate in Women Designated for Standard Intrauterine Insemination IUI
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIE
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None