Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination
|ClinicalTrials.gov Identifier: NCT00745563|
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : June 9, 2011
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:
- Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution (Cup insemination, CI) upon the cervix.
- Spermatozoa injection (after improvement) through the vagina to the cervix (Intra-Cervical Insemination, ICI).
- 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.
- 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.
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
Four weeks after insemination - US Viability scan
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Device: Fertiligent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testing the Effect of Intra-uterine Slow-Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Artificial Insemination|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
Fertility treatment by using the EVIE - Slow Release Insemination method
- 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 [ Time Frame: 2 weeks following procedure ]
- Four weeks after insemination - US Viability scan [ Time Frame: 4 weeks following procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745563
|Carmel Medical Center|
|Haifa, Israel, 31048|
|Principal Investigator:||Martha Dirnfeld, Prof.||Carmel medical Center, Haifa Israel|