Effects of Intra-Uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination
Information source: Fertiligent
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Fertiligent (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Fertiligent Official(s) and/or principal investigator(s):
Martha Dirnfeld, Prof., Principal Investigator, Affiliation: Carmel medical Center, Haifa Israel
Overall contact:
Hanna Levy, Dr., Phone: (972)-4-638-8837, Email: hanna@qsitemed.com
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.
Clinical Details
Official title: Testing the Effect of Intra-Uterine Slow-Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Artificial Insemination
Study design: Treatment, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: 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 outcome: Four weeks after insemination - US Viability scan
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Primary or secondary infertility designated for IUI treatment.
- Age of candidates: 20-40 years.
- Normal uterus x-ray.
- Women suffering from infertility on a background of non-ovulation.
- Infertility on a background of male problems (over 10 million of motile sperm cells
per sample).
- Infertility on background of unexplained problem
- Same sex patients / single patient
- Written informed consent
Exclusion Criteria:
- Woman under the age of 20 or over the age of 40 years.
- Female infertility on mechanical background (different blockages, irregular uterus).
- Infertility on male background of medium to very low level of spermatozoa - less than
10 million 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.
Locations and Contacts
Hanna Levy, Dr., Phone: (972)-4-638-8837, Email: hanna@qsitemed.com
Carmel Medical Center, Haifa 31048, Israel; Recruiting
Hanna Levy, Dr., Phone: (972)-4-638-8837, Email: hanna@qsitemed.com
Additional Information
Starting date: October 2008
Ending date: December 2009
Last updated: December 27, 2008
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