Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00745563
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2008-08-30
Brief Title:
Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination
Sponsor:
Fertiligent
Organization:
Fertiligent
Study Overview
Official Title:
Testing the Effect of Intra-uterine Slow-Release Insemination SRI on the Pregnancy Rate in Women Designated for Artificial Insemination
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
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:
None
Brief Summary:
A couple that does not achieve pregnancy though regular attempts for a year are defined infertile couple This condition is caused by faulty functioning of the reproduction system of the husband or wife or both If there are no organic defects and there is no definite injury to the reproductive system ova or spermatozoa the specialist doctor generally decides to put the couple into a fertility treatment program Artificial insemination is one of the important ways of achieving pregnancy
Three common methods of artificial insemination
1 Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution Cup insemination CI upon the cervix
2 Spermatozoa injection after improvement through the vagina to the cervix Intra-Cervical Insemination ICI
3 Spermatozoa injection after improvement directly into the uterus IUI-Intra-Uterine Insemination
The EVIE - Slow Release Insemination method
The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours The release rate for motile spermatozoa is 50X103 per minute
Advantages
Very close approximation of the natural procedure in which the spermatozoa arrive to the fertilization site over a long period
An extended window of opportunities for meeting between the ovum and spermatozoa will be longer
There is no loss of spermatozoa due to leaking as sometimes happens with single-time injection practiced in the IUI method
Primary Endpoint
Accumulation of 50 cycles of SRI- slow release insemination study group in addition to 50 cycles of regular IUI control group Two weeks after insemination Beta hCG test
Secondary Endpoints
Four weeks after insemination - US Viability scan
Procedure
Subjects will be women with fertility difficulties who are designated for IUI treatment 100 insemination cycles will be conducted 50 regular IUI and 50 EVIE-SRI Subjects that were treated with the IUI method and who does not become pregnant will then be treated with the EVIE-Slow Release method and vice versa
Three common methods of artificial insemination
1 Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution Cup insemination CI upon the cervix
2 Spermatozoa injection after improvement through the vagina to the cervix Intra-Cervical Insemination ICI
3 Spermatozoa injection after improvement directly into the uterus IUI-Intra-Uterine Insemination
The EVIE - Slow Release Insemination method
The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours The release rate for motile spermatozoa is 50X103 per minute
Advantages
Very close approximation of the natural procedure in which the spermatozoa arrive to the fertilization site over a long period
An extended window of opportunities for meeting between the ovum and spermatozoa will be longer
There is no loss of spermatozoa due to leaking as sometimes happens with single-time injection practiced in the IUI method
Primary Endpoint
Accumulation of 50 cycles of SRI- slow release insemination study group in addition to 50 cycles of regular IUI control group Two weeks after insemination Beta hCG test
Secondary Endpoints
Four weeks after insemination - US Viability scan
Procedure
Subjects will be women with fertility difficulties who are designated for IUI treatment 100 insemination cycles will be conducted 50 regular IUI and 50 EVIE-SRI Subjects that were treated with the IUI method and who does not become pregnant will then be treated with the EVIE-Slow Release method and vice versa
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