Intrauterine InseminationPhase 4NCT00503217
GnRH Agonist and Intrauterine Insemination
A Phase 4 study testing Tryptorelin in people with Intrauterine Insemination, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
The aim of this study is to assess whether GnRH agonist administration in the luteal phase improves pregnancy outcome in intrauterine insemination (IUI) cycles. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Insemination
- What is being tested?
- Tryptorelin
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Feb 2005to Dec 2007
- Phase
- Phase 4
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women < 38 years old
- Bilateral tubal patency confirmed by hysterosonography
- Normal ultrasound scan of uterus and ovaries
- Normal day 3 basal hormones
- Motile sperm count after capacitation ≥ 3 mill/ml
Who cannot join
- Endometriosis
- Polycystic ovary syndrome
- Uterine disease (polyps, myomas and müllerian diseases)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Valenciano de Infertilidad Spain
Valencia, Valencia, 46015
About this study
Official title: Effect of GnRH Agonist Administration at the Time of Implantation in Intrauterine Insemination Cycles: A Randomized Controlled Trial
The aim of this study is to assess whether GnRH agonist administration in the luteal phase improves pregnancy outcome in intrauterine insemination (IUI) cycles.
- Conditions
- Intrauterine Insemination
- Being tested
- Tryptorelin
- Keywords
- intrauterine insemination, GnRH agonist, implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TryptorelinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Bellver, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Jose Bellver, MD, Principal investigator, Instituto Valenciano de la InfertilidadElena Labarta, MD, Principal investigator, Instituto Valenciano de Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503217
- Sponsor's protocol ID
- VLC-JB-0205-307-9
- Status last verified
- Sep 2016
- First submitted
- 17 Jul 2007
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GnRH Agonist Administration at the Time of Implantation in Intrauterine Insemination Cycles: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00503217
- Acronym / sponsor ID
- VLC-JB-0205-307-9
- Conditions
- Intrauterine Insemination
- Keywords
- intrauterine insemination, GnRH agonist, implantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Jul 2007 (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 aim of this study is to assess whether GnRH agonist administration in the luteal phase improves pregnancy outcome in intrauterine insemination (IUI) cycles.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women < 38 years old
- Bilateral tubal patency confirmed by hysterosonography
- Normal ultrasound scan of uterus and ovaries
- Normal day 3 basal hormones
- Motile sperm count after capacitation ≥ 3 mill/ml
Key exclusion criteria (3 listed)
- Endometriosis
- Polycystic ovary syndrome
- Uterine disease (polyps, myomas and müllerian diseases)
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 |
|---|---|---|
| Tryptorelin | Drug | – |
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 7 Sep 2016.
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Sperm Preparation Prior to Intrauterine Insemination Study
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Progesterone Supplementation After Letrozole-stimulated Insemination
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The Efficacy and Safety of Female PRP Co-incubation With Sperm During (IUI) Cycles
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Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
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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.
Jose Bellver, MD principal investigator
Instituto Valenciano de la Infertilidad
Elena Labarta, MD principal investigator
Instituto Valenciano de Infertilidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tryptorelin in people with Intrauterine Insemination, run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 5 inclusion and 3 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 7 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 7 Sep 2016.