Role of Intrauterine Insemination in Patients With Endometriosis I-II

Completed

• Conditions: Endometriosis I-II
• Interventions: Procedure: Intrauterine insemination

• Registration Number: NCT03425604
• Lead Sponsor: IVI Bilbao

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2017-01
• Study Completion: 2017-06
• Status Verified: 2018-02
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-07
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9979

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometriosis I y II, according to ASRM classification	Intrauterine insemination	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
patients without endometriosis	Intrauterine insemination	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

Primary Outcome Measures

Name	Time	Method
pregnancy rate	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