Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    intra uterine insemination | Endometriosis
Previous Study | Return to List | Next Study

Role of Intrauterine Insemination in Patients With Endometriosis I-II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03425604
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
IVI Bilbao

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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

Condition or disease Intervention/treatment
Endometriosis I-II Procedure: Intrauterine insemination

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 9979 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Role of Intrauterine Insemination in Patients With Endometriosis I-II
Actual Study Start Date : January 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
 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
 Procedure: Intrauterine insemination


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We analyzed the database (SIVIS) containing information on IUI treatment cycles carried out at the IVI-Clinics between 2011 and 2017.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: IVI Bilbao
ClinicalTrials.gov Identifier: NCT03425604    
Other Study ID Numbers: IVIBILBAO
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis