InseminationUGAINCT00809952
Ultrasound Guided Artificial Insemination
An observational study of Insemination, run by Hospital de Cruces at 1 site in Spain.
Trial summary
The purpose of this study is to ascertain whether using ultrasound guidance during intrauterine insemination (IUI) could increase pregnancy rates. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insemination
- What is being tested?
- recombinant FSH
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The woman's inclusion criteria in our IUI program were at least one patent tube, normal cavity, basal FSH < 10 mU/mL and age under 40 years.
- IUI with husband's sperm (IUI-H) was indicated when, after sperm preparation, at least 5 million motile spermatozoa were recovered; this was performed in 58 cases (79.45%).
- In the remaining 15 cases (20.55%), IUI was performed with donor sperm (IUI-D) either because of azoospermia (n=6) failure to recover spermatozoa during testicular biopsy (n=5) or in women without a male partner (n=4).
Who cannot join
- Previous infertility treatments had been carried out.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to ascertain whether using ultrasound guidance during intrauterine insemination (IUI) could increase pregnancy rates.
- Conditions
- Insemination
- Being tested
- recombinant FSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant FSHProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Recombinat FSH | Not described Receives: Procedure: recombinant FSH |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InseminationStudies 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
- Observational
Sponsor and investigators
- Lead sponsor
- Hospital de Cruces
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809952
- Sponsor's protocol ID
- HUMREP-08-0656
- Acronym
- UGAI
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
Publications
Ramon O, Matorras R, Corcostegui B, Meabe A, Burgos J, Exposito A, Crisol L. Ultrasound-guided artificial insemination: a randomized controlled trial. Hum Reprod. 2009 May;24(5):1080-4. doi: 10.1093/humrep/den498. Epub 2009 Feb 5.
PubMed 19196748
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Artificial Insemination
- ClinicalTrials.gov ID
- NCT00809952
- Acronym / sponsor ID
- UGAI / HUMREP-08-0656
- Conditions
- Insemination
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Hospital de CrucesUniversity, hospital or other
- First posted
- 17 Dec 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.
The purpose of this study is to ascertain whether using ultrasound guidance during intrauterine insemination (IUI) could increase pregnancy rates.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinat FSH | – | Procedure: recombinant FSH |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The woman's inclusion criteria in our IUI program were at least one patent tube, normal cavity, basal FSH < 10 mU/mL and age under 40 years.
- IUI with husband's sperm (IUI-H) was indicated when, after sperm preparation, at least 5 million motile spermatozoa were recovered; this was performed in 58 cases (79.45%).
- In the remaining 15 cases (20.55%), IUI was performed with donor sperm (IUI-D) either because of azoospermia (n=6) failure to recover spermatozoa during testicular biopsy (n=5) or in women without a male partner (n=4).
Key exclusion criteria (1 listed)
- Previous infertility treatments had been carried out.
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 |
|---|---|---|
| recombinant FSH | Procedure or surgery | Recombinat FSH |
Primary outcome
Not reported in the source record.
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 17 Dec 2008.
- Derived from this study: PubMed 19196748Ramon O, Matorras R, Corcostegui B, Meabe A, Burgos J, Exposito A, Crisol L. Ultrasound-guided artificial insemination: a randomized controlled trial. Hum Reprod. 2009 May;24(5):1080-4. doi: 10.1093/humrep/den498. Epub 2009 Feb 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insemination, run by Hospital de Cruces at 1 site in Spain.
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 3 inclusion and 1 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 17 Dec 2008. 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 Spain. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809952, which also lists 1 linked publication.
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 17 Dec 2008.