Infertility Clinical Trial
Official title:
Testing the Effect of Intra-uterine Slow-Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Artificial Insemination
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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