Role of Intrauterine Insemination in Patients With Endometriosis I-II

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 Overview

• Status: Completed
• Conditions: Endometriosis I-II
• Intervention / Treatment: Procedure: Intrauterine insemination

• Study Type: Observational
• Enrollment (Actual): 9979

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IVI Bilbao

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: IVIBILBAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No