Endometriosis I-II Clinical Trial
Official title:
Role of Intrauterine Insemination in Patients With Endometriosis I-II
| NCT number | NCT03425604 |
| Other study ID # | IVIBILBAO |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2011 |
| Est. completion date | June 2017 |
| Verified date | February 2018 |
| Source | IVI Bilbao |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 9979 |
| Est. completion date | June 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 38 Years |
| Eligibility |
Inclusion Criteria:< 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 - Exclusion Criteria: - > 38 years old |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| IVI Bilbao |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 2011-2017 |