Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination

Withdrawn

• Conditions: Primary Infertility

• Registration Number: NCT02704936
• Lead Sponsor: IVI Bilbao

Brief Summary

Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)

Detailed Description

Analyze lipid profiles in samples of sperm and seminal plasma of three populations:

1. male sperm donors

2. men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;

3. attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI

Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.

Assess markers found by checking the increase in the rate of success in the IA.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination	18 months	Levels of docosahexaenoic acid (DHA) and acid eicosapentaenoic (EPA) in 42 semen samples: * With positive pregnancy in any of the first 4 treatments of artificial insemination.; * Gestacion Negative in artificial insemination; * Assigned to the program-donors donation

Secondary Outcome Measures

Name	Time	Method
Descriptive analysis of semen parameters versus DHA and EPA levels	18 months	Correlation analysis of seminal variables: sperm count, motility and morphology percent compared to the levels of DHA and EPA obtained.; Assuming normal distribution continuous variables, ANOVA test apply. If the normality assumption failed an Kruskal-Wallis test was applied.

Trial Locations

Locations (1)

IVI Bilbao; 🇪🇸 Leioa, Vizcaya, Spain