NCT03425604

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,979

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2018

Enrollment Period

6 years

First QC Date

February 1, 2018

Last Update Submit

February 11, 2020

Conditions

Endometriosis I-II

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Interventions

Intrauterine inseminationPROCEDURE
Endometriosis I y II, according to ASRM classificationpatients without endometriosis

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may not qualify if:

  • \> 38 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

January 1, 2011

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

February 12, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share