Endometriosis I-IINCT03425604
Role of Intrauterine Insemination in Patients With Endometriosis I-II
An observational study of Endometriosis I-II, run by IVI Bilbao.
Trial summary
Intrauterine insemination (IUI) is an ART that provides good results in selected patients, improving their reproductive prognosis. Endometriosis I y II, according to ASRM classification, remains an indication to perform IUI. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Endometriosis I-II
- What is being tested?
- Intrauterine insemination
- Type of treatment
- Surgery or procedure
- How many people
- 9,979 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2017
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: We analyzed the database (SIVIS) containing information on IUI treatment cycles carried out at the IVI-Clinics between 2011 and 2017.
Who may be able to join
None listed.
Who cannot join
- > 38 years old
About this study
Intrauterine insemination (IUI) is an ART that provides good results in selected patients, improving their reproductive prognosis. Endometriosis I y II, according to ASRM classification, remains an indication to perform IUI. This indication is on continuous debate, considering that different studies have shown controversial results about it, due to the poor reproductive outcomes in this group of patients
- Conditions
- Endometriosis I-II
- Being tested
- Intrauterine insemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine inseminationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis I y II, according to ASRM classification | Cycles were chosen for analysis only when all the following selection criteria were satisfied: < 38 years old women, antral follicle count > 6, basal FSH < 10mUI/ml, BMI<30, Infertility time <4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, < 3 previous IUI cycles, no male severe factor associated Receives: Procedure: Intrauterine insemination | |
| patients without endometriosis | Cycles were chosen for analysis only when all the following selection criteria were satisfied: < 38 years old women, antral follicle count > 6, basal FSH < 10mUI/ml, BMI<30, Infertility time <4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, < 3 previous IUI cycles, no male severe factor associated Receives: Procedure: Intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
to compare pregnancy rate between Endometriosis I-II patients (according to ASRM classification) vs. control group (patients without endometriosis) going under an IUI cycle
Measured: 2011-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study startJan 2011
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis I-IIStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9,979 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425604
- Sponsor's protocol ID
- IVIBILBAO
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intrauterine Insemination in Patients With Endometriosis I-II
- ClinicalTrials.gov ID
- NCT03425604
- Acronym / sponsor ID
- IVIBILBAO
- Conditions
- Endometriosis I-II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,979 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Feb 2018 (actual)
- 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.
Intrauterine insemination (IUI) is an ART that provides good results in selected patients, improving their reproductive prognosis. Endometriosis I y II, according to ASRM classification, remains an indication to perform IUI. This indication is on continuous debate, considering that different studies have shown controversial results about it, due to the poor reproductive outcomes in this group of patients
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis I y II, according to ASRM classification | – | Procedure: Intrauterine inseminationCycles were chosen for analysis only when all the following selection criteria were satisfied: < 38 years old women, antral follicle count > 6, basal FSH < 10mUI/ml, BMI<30, Infertility time <4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, < 3 previous IUI cycles, no male severe factor associated |
| patients without endometriosis | – | Procedure: Intrauterine inseminationCycles were chosen for analysis only when all the following selection criteria were satisfied: < 38 years old women, antral follicle count > 6, basal FSH < 10mUI/ml, BMI<30, Infertility time <4 years, absence of uterine malformations, endometrial polyps or myomas, absence of known thrombofilia, normal kayotype, < 3 previous IUI cycles, no male severe factor associated |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We analyzed the database (SIVIS) containing information on IUI treatment cycles carried out at the IVI-Clinics between 2011 and 2017.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- > 38 years old
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 |
|---|---|---|
| Intrauterine insemination | Procedure or surgery | Endometriosis I y II, according to ASRM classification, patients without endometriosis |
Primary outcome
pregnancy rate
Time frame: 2011-2017
to compare pregnancy rate between Endometriosis I-II patients (according to ASRM classification) vs. control group (patients without endometriosis) going under an IUI cycle
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 12 Feb 2020.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis I-II, run by IVI Bilbao.
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 0 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
pregnancy rate (time frame: 2011-2017). 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 12 Feb 2020.