InfertilityNCT00745563
Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination
A study testing Fertiligent in people with Infertility, run by Fertiligent at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Fertiligent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
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.
- Conditions
- Infertility
- Being tested
- Fertiligent
- Keywords
- infertility, insemination, slow release
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertiligentDevice
Fertility treatment by using the EVIE - Slow Release Insemination method
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Fertiligent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks following procedure
Secondary outcomes (1)
Four weeks after insemination - US Viability scan
Measured: 4 weeks following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertiligent
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martha Dirnfeld, Prof., Principal investigator, Carmel medical Center, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745563
- Sponsor's protocol ID
- BRIDGE1 20/7/2008
- Status last verified
- Dec 2008
- First submitted
- 30 Aug 2008
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effect of Intra-uterine Slow-Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Artificial Insemination
- ClinicalTrials.gov ID
- NCT00745563
- Acronym / sponsor ID
- BRIDGE1 20/7/2008
- Conditions
- Infertility
- Keywords
- infertility, insemination, slow release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- FertiligentIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Fertiligent |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FertiligentFertility treatment by using the EVIE - Slow Release Insemination method | Device | A |
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
Time frame: 2 weeks following procedure
1 secondary outcome
Four weeks after insemination - US Viability scan
Time frame: 4 weeks following procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Dirnfeld, Prof. principal investigator
Carmel medical Center, Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fertiligent in people with Infertility, run by Fertiligent at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.